Study of TAK-071 in Healthy Participants and Participants With Mild Cognitive Impairment/Mild Alzheimer Disease and Relative Bioavailability (BA) and Food Effect of TAK-071 in Healthy Participants

NCT02769065 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: TAK-071-1001U1111-1176-7435
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to assess the safety, tolerability, and pharmacokinetic (PK) of TAK-071 when administered as single rising dose (SRD) and multiple rising dose (MRD) orally in healthy participants and participants with mild cognitive impairment (MCI) or mild Alzheimer disease (AD).

Conditions

Alzheimer Disease; Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (42)

• Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)

  An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs or gets worse after receiving study drug.

  Day 1 up to Day 41

• Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose

  Clinical laboratory tests included serum chemistry, hematology, coagulation and urinalysis. ULN=upper limit of normal range.

  Day 1 up to Day 41

• Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose

  Vital Sign measurements included systolic blood pressure (SBP), diastolic blood presssure (DBP), pulse, temperature, orthostatic SBP, orthostatic DBP and orthostatic pulse.

  Day 1 up to Day 41

• Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose

  A standard 12-lead electrocardiogram (ECG) was performed. The percentage of participants with markedly abnormal ECG findings during the study.

  Day 1 up to Day 41

• Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants

  Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

• Tmax: Time of First Occurrence of Cmax for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]

  Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

• Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21]

  Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose

• Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1]

  Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

• Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 8]

  Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose

• Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 28]

  Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose

• Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 1]

  Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

• Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 8]

  Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose

• Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 28]

  Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

• Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1]

  Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

• Tmax: Time of First Occurrence of Cmax for TAK-071 Relative Bioavailability and Food Effect

  Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose

• Tmax: Time of First Occurrence of Cmax for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

  Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants

  Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]

  Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21]

  Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1]

  Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 8]

  Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 28]

  Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 1]

  Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 8]

  Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 28]

  Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1]

  Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-071 Relative Bioavailability and Food Effect

  Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose

• Cmax: Maximum Observed Plasma Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

  Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

• AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants

  Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

• AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]

  Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

• AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21]

  Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose

• AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1]

  Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

• AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 8]

  Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose

• AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 28]

  Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose

• AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 1]

  Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose

• AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 8]

  Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose

• AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 28]

  Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose

• AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1]

  Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose

• AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 Relative Bioavailability and Food Effect

  Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose

• AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil

  Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

• AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants

  Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose

• AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil

  Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose

Secondary Outcomes (41)

• AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants

  Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose

• AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants

  Pre-dose on Day 1 and multiple timepoints (up to 24 hrs) post-dose for Cohorts 7 and 8 and Pre-dose on Day 1 and multiple timepoints (up to 96 hrs) post-dose for Cohort 9

• AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants

  Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose and Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose

• AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese

  Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose

• AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 Relative Bioavailability and Food Effect

  Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose

Study Arms (30)

SRD: Placebo Cohorts 1-6, 18 and 19

PLACEBO COMPARATOR

TAK-071 placebo-matching capsules, orally, once on Day 1 to non-Japanese healthy participants in the single-rising dose (SRD) period.

Drug: TAK-071 Placebo

SRD: Cohort 1: TAK-071 1 mg

EXPERIMENTAL

TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants.

Drug: TAK-071

SRD: Cohort 2: TAK-071 3 mg

EXPERIMENTAL

TAK-071 3 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety, tolerability and pharmacokinetic (PK) data from cohort 1.

Drug: TAK-071

SRD: Cohort 3: TAK-071 9 mg

EXPERIMENTAL

TAK-071 9 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK and 12-hour CSF PK data.

Drug: TAK-071

SRD: Cohort 4: TAK-071 20 mg

EXPERIMENTAL

TAK-071 20 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety and tolerability data from previous cohort.

Drug: TAK-071

SRD: Cohort 5: TAK-071 40 mg

EXPERIMENTAL

TAK-071 40 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 will be based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 4.

Drug: TAK-071

SRD: Cohort 6: TAK-071 80 mg

EXPERIMENTAL

TAK-071 80 mg capsules, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 5

Drug: TAK-071

MRD: Placebo Cohorts 7-9

PLACEBO COMPARATOR

TAK-071 placebo-matching capsule, orally, once on Day 1 to non-Japanese healthy participants in the multiple-rising dose (MRD) period.

Drug: TAK-071 Placebo

MRD: Cohort 7: TAK-071 3 mg

EXPERIMENTAL

TAK-071 3 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability from Cohort 4 and the 24-hour preliminary plasma PK and 12-hour CSF PK data from Cohort 3.

Drug: TAK-071

MRD: Cohort 8: TAK-071 9 mg

EXPERIMENTAL

TAK-071 9 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort.

Drug: TAK-071

MRD: Cohort 9: TAK-071 15 mg

EXPERIMENTAL

TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to non-Japanese healthy participants. Dose of TAK-071 will be based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort.

Drug: TAK-071

MRD: TAK-071 Placebo Cohorts 10-12+Donepezil

PLACEBO COMPARATOR

TAK-071 placebo-matching capsule, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071.

Drug: Donepezil; Drug: TAK-071 Placebo

MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg

EXPERIMENTAL

TAK-071 3 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 7.

Drug: TAK-071; Drug: Donepezil

MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg

EXPERIMENTAL

TAK-071 9 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 8.

Drug: TAK-071; Drug: Donepezil

MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg

EXPERIMENTAL

TAK-071 15 mg capsule, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 9.

Drug: TAK-071; Drug: Donepezil

MRD: Placebo Cohorts 13-15

EXPERIMENTAL

TAK-071 placebo-matching capsule, orally, once on Day 1 to Japanese healthy participants.

Drug: TAK-071 Placebo

MRD: Cohort 13: TAK-071 3 mg

EXPERIMENTAL

TAK-071 3 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 7.

Drug: TAK-071

MRD: Cohort 14: TAK-071 9 mg

EXPERIMENTAL

TAK-071 9 mg capsule or matching placebo, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 8.

Drug: TAK-071

MRD: Cohort 15: TAK-071 15 mg

EXPERIMENTAL

TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 9.

Drug: TAK-071

Cohort 16

EXPERIMENTAL

Drug: TAK-071

Bioavailability (BA)/Food Effect: Cohort 17 Sequence ABC

EXPERIMENTAL

A: TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1, followed by B: TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 2, followed by C: TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 3 in non-Japanese healthy participants. There was a 21-day washout after each period.

Drug: TAK-071

BA/Food Effect: Cohort 17 Sequence BCA

EXPERIMENTAL

B: TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1, followed by C: TAK-071 10 mg tablet, orally, once on Day 1 in the Fed state in Period 2, followed by A: TAK-071 10 mg capsule, orally once on Day 1 in the fasted state Period 3 in non-Japanese healthy participants. There was a 21-day washout after each period.

Drug: TAK-071

BA/Food Effect: Cohort 17 Sequence CAB

EXPERIMENTAL

C: TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1, followed by A: TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 2, followed by B: TAK-20 10 mg tablet, orally, once on Day 1 in the fasted state in Period 3 in non-Japanese healthy participants. There was a 21-day washout after each period.

Drug: TAK-071

SRD: Cohort 18: TAK-071 120 mg

EXPERIMENTAL

TAK-071 120 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 6.

Drug: TAK-071

SRD: Cohort 19: TAK-071 160 mg

EXPERIMENTAL

TAK-071 160 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 18.

Drug: TAK-071

SRD: TAK-071 Placebo+Donepezil Placebo

PLACEBO COMPARATOR

TAK-071 placebo-matching capsule, orally, once on Day 1 followed by donepezil placebo-matching tablet, orally on Day 2 to non-Japanese healthy participants.

Drug: TAK-071 Placebo; Drug: Donepezil Placebo

SRD: TAK-071 Placebo+Donepezil

PLACEBO COMPARATOR

TAK-071 placebo-matching capsule, orally, once on Day 1 followed by donepezil 10 mg tablet, orally, on Day 2 to non-Japanese healthy participants.

Drug: Donepezil; Drug: TAK-071 Placebo

SRD: Cohort 20: TAK-071 40 mg+Donepezil

EXPERIMENTAL

TAK-071 40 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 19.

Drug: TAK-071; Drug: Donepezil

SRD: Cohort 21: TAK-071 60 mg+Donepezil

EXPERIMENTAL

TAK-071 60 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 20.

Drug: TAK-071; Drug: Donepezil

SRD: Cohort 22: TAK-071 80 mg+Donepizil

EXPERIMENTAL

TAK-071 80 mg capsule, orally, once on Day 1, followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 21.

Drug: TAK-071; Drug: Donepezil

Interventions

TAK-071 DRUG

TAK-071 capsules

BA/Food Effect: Cohort 17 Sequence BCA; BA/Food Effect: Cohort 17 Sequence CAB; Bioavailability (BA)/Food Effect: Cohort 17 Sequence ABC; Cohort 16; MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg; MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg; MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg; MRD: Cohort 13: TAK-071 3 mg; MRD: Cohort 14: TAK-071 9 mg; MRD: Cohort 15: TAK-071 15 mg; MRD: Cohort 7: TAK-071 3 mg; MRD: Cohort 8: TAK-071 9 mg; MRD: Cohort 9: TAK-071 15 mg; SRD: Cohort 18: TAK-071 120 mg; SRD: Cohort 19: TAK-071 160 mg; SRD: Cohort 1: TAK-071 1 mg; SRD: Cohort 20: TAK-071 40 mg+Donepezil; SRD: Cohort 21: TAK-071 60 mg+Donepezil; SRD: Cohort 22: TAK-071 80 mg+Donepizil; SRD: Cohort 2: TAK-071 3 mg; SRD: Cohort 3: TAK-071 9 mg; SRD: Cohort 4: TAK-071 20 mg; SRD: Cohort 5: TAK-071 40 mg; SRD: Cohort 6: TAK-071 80 mg

Donepezil DRUG

Donepezil over-encapsulated tablet

MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg; MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg; MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg; MRD: TAK-071 Placebo Cohorts 10-12+Donepezil; SRD: Cohort 20: TAK-071 40 mg+Donepezil; SRD: Cohort 21: TAK-071 60 mg+Donepezil; SRD: Cohort 22: TAK-071 80 mg+Donepizil; SRD: TAK-071 Placebo+Donepezil

TAK-071 Placebo DRUG

TAK-071 placebo-matching capsules

MRD: Placebo Cohorts 13-15; MRD: Placebo Cohorts 7-9; MRD: TAK-071 Placebo Cohorts 10-12+Donepezil; SRD: Placebo Cohorts 1-6, 18 and 19; SRD: TAK-071 Placebo+Donepezil; SRD: TAK-071 Placebo+Donepezil Placebo

Donepezil Placebo DRUG

Donepezil placebo-matching over-encapsulated tablet

SRD: TAK-071 Placebo+Donepezil Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman who weighs at least 50 kg and has a body mass index (BMI) from 18.0 to 30.0 kg/m\^2, inclusive, at Screening. Participants should be aged 18 to 55 years, inclusive (nonelderly at the time of informed consent and first study drug dose) for Cohorts 1 to 12, and 17 to 22; 20 to 55 years, inclusive, for Cohorts 13 to 15; and 55 to 90 years, inclusive, for participants in Cohort 16.
• For Cohorts 13 to 15 only: First-generation Japanese, defined as having been born in Japan of Japanese parents and Japanese grandparents and living no more than 10 years outside of Japan, with no significant change in lifestyle, including diet, while living outside of Japan.
• Cohort 16 only: Healthy elderly or participants with MCI or mild AD, who must have Mini Mental State Examination (MMSE) score of 18 to 30, inclusive or 18 to 26 inclusive, respectively, and no biomarker data to contradict this diagnosis. Participants with documented diagnosis of MCI or mild AD must be receiving ongoing donepezil therapy (10 mg) in the evening for a minimum of 21 days prior to Check-in (Day -1) or must consent to take donepezil dose titrated to at least 21 days of treatment with 10 mg QD prior to Check-in.

You may not qualify if:

• Has clinically significant (Cohorts 1 to 15 and 17 to 22) or uncontrolled (Cohort 16) neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal (GI), urologic, immunologic, endocrine, or psychiatric disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results.
• Has a history of type 1 diabetes (Cohorts 1 to 22) or type 2 diabetes (Cohorts 1 to 15, 17 to 22) or hemoglobin A1c \>6.5% at Screening. Note: participants with controlled (hemoglobin A1c \<7.0% at Screening) type 2 diabetes in Cohort 16 may participate in the study.
• Has a risk of suicide or suicidal ideation with intent and plan according to the investigator's clinical judgment (affirmative answer to questions 4 and 5 of the ideation section of the Columbia-Suicide Severity Rating Scale) or has made a suicide attempt in the previous 6 months.
• Cohort 16 only: Any significant neurologic disease (other than suspected incipient or mild AD), such as Parkinson disease, stroke, transient ischemic attack, multi-infarct dementia, Huntington disease, head trauma with clinically significant cognitive sequelae, or chronic central nervous system infection, per investigator discretion.
• Has current or recent (within 6 months) GI disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, any surgical intervention known to impact absorption \[eg, bariatric surgery or bowel resection\], esophageal reflux, peptic ulcer disease, erosive esophagitis, or frequent \[more than once per week\] occurrence of heartburn).

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Glendale, California, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

TAK-071; Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Medical Director, Clinical Science
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 11, 2016
• Study Start: May 5, 2016
• Primary Completion: June 8, 2017
• Study Completion: June 8, 2017
• Last Updated: June 10, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-03

Locations

US (1)