Safety, Tolerability, and Pharmacokinetics of Multiple-Dose TAK-058 in Healthy Participants

NCT02389881 | Completed Phase 1 Results DMC

• 2 other identifiers: TAK-058-1002U1111-1165-3644
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of TAK-058 in healthy non-elderly and elderly participants.

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event

  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. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

  Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14

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

  The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry and hematology) collected throughout study.

  Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14

• Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs at Least Once Post-Dose

  The percentage of participants with any markedly abnormal standard vital sign values collected throughout study. Vital signs included blood pressure (after 5 minutes supine and at 1 and 3 minutes after standing), pulse and oral temperature.

  Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14

Secondary Outcomes (4)

• Mean Cmax: Maximum Observed Plasma Concentration for TAK-058

  Day 1 predose and at multiple time points (up to 72 hours) postdose, and Day 10 predose and at multiple time points (up to 24 hours) postdose

• Mean AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-058

  Day 1 predose and at multiple time points (up to 72 hours) postdose

• Mean AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-058

  Day 1 predose and at multiple time points (up to 24 hours) postdose

• Mean AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-058

  Day 10 predose and at multiple time points (up to 24 hours) postdose

Study Arms (7)

Cohort 1 Non-elderly Healthy: TAK-058 25 mg

EXPERIMENTAL

TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.

Drug: TAK-058

Cohort 2 Non-elderly Healthy: TAK-058 75 mg

EXPERIMENTAL

TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.

Drug: TAK-058

Cohort 3 Non-elderly Healthy: TAK-058 150 mg

EXPERIMENTAL

TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.

Drug: TAK-058

Cohort 4 Elderly Healthy: TAK-058 25 mg

EXPERIMENTAL

TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.

Drug: TAK-058

Cohort 5 Non-elderly Healthy: TAK-058 300 mg

PLACEBO COMPARATOR

TAK-058 300 mg solution, orally, once daily on Day 1, in non-elderly healthy participants.

Drug: TAK-058

Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo

PLACEBO COMPARATOR

TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.

Drug: TAK-058 Placebo

Cohort 4 Elderly Healthy: Placebo

PLACEBO COMPARATOR

TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.

Drug: TAK-058 Placebo

Interventions

TAK-058 DRUG

TAK-058 Solution

Cohort 1 Non-elderly Healthy: TAK-058 25 mg; Cohort 2 Non-elderly Healthy: TAK-058 75 mg; Cohort 3 Non-elderly Healthy: TAK-058 150 mg; Cohort 4 Elderly Healthy: TAK-058 25 mg; Cohort 5 Non-elderly Healthy: TAK-058 300 mg

TAK-058 Placebo DRUG

TAK-058 placebo-matching solution

Cohort 4 Elderly Healthy: Placebo; Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo

Eligibility Criteria

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

You may qualify if:

• Ages for this study are 18 to 60 years for non-elderly and 18 to 65 years for elderly.
• A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
• A female participant with no childbearing potential, which is defined as the subject has been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least 2 years and follicle-stimulating hormone \[FSH\]\>40 IU/L).
• Weighs at least 45 kg (99 lbs) and has a body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive at Screening.

You may not qualify if:

• Has received any investigational compound within 30 days prior to the first dose of study medication.
• Has received TAK-058 in a previous clinical study.
• Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
• Has a known hypersensitivity to any component of the formulation of TAK-058.
• Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
• Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 6 months prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
• Female participants of childbearing potential (premenopausal, non-sterilized), or has a positive pregnancy test.
• Male participants that intend to donate sperm during the course of this study or for 12 weeks thereafter.
• Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. There is any finding in the subject's medical history, physical examination, or safety laboratory tests giving reasonable suspicion of a disease that would contraindicate taking TAK-058, or a similar drug in the same class, or that might interfere with the conduct of the study. This includes, but is not limited to, peptic ulcer disease, seizure disorders and cardiac arrhythmias.
• Has previously had a seizure or convulsion (lifetime), including absence seizure and febrile convulsion.
• Has current or recent (within 6 months) gastrointestinal 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).
• Has a history of cancer or other malignancy, except basal cell carcinoma that has been in remission for at least 5 years prior to Day 1.
• Has a positive test result for hepatitis B surface antigen (HBsAg), antibody to hepatitis C virus (anti-HCV) or a known history of human immunodeficiency virus infection at Screening.
• Has poor peripheral venous access.
• Has donated or lost 450 mL or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to Day 1.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Austsitn, Texas, United States

Location

Results Point of Contact

• Title: Medical Director
• 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: March 10, 2015
• First Posted: March 17, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 23, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-01

Locations

US (1)