Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-137 in Healthy Participants

NCT02334982 | Completed Phase 1 Results

• 2 other identifiers: TAK-137_101U1111-1164-7376
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to characterize the safety and tolerability profile of TAK-137 when administered as a single dose of tablets at escalating dose levels in healthy participants.

Conditions

Dose Finding Study

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 is defined as an adverse event with an onset that occurs after receiving study drug.

  Day 1 to 14 days after the last dose of study medication(Up to 30 days)

• Percentage of Participants With Abnormal Safety Laboratory Findings

  The percentage of participants with any markedly abnormal standard safety laboratory values was collected throughout study.

  Day 1 to 14 days after the last dose of study medication (Up to 30 Days)

• Percentage of Participants With Markedly Abnormal Vital Sign Measurements

  The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.

  Day 1 to 14 days after the last dose of study medication

Secondary Outcomes (10)

• Cmax: Maximum Observed Plasma Concentration for TAK-137

  Day 1

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137

  Day 1

• AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-137

  Day 1

• AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-137

  Day 1

• Terminal Elimination Half-life (T1/2) for TAK-137_101

  Day 1

Study Arms (7)

Cohort 1: TAK-137 2 mg

EXPERIMENTAL

TAK-137 2 mg, tablets, orally, once on Day 1.

Drug: TAK-137

Cohort 2: TAK-137 5 mg

EXPERIMENTAL

TAK-137 5 mg, tablets, orally, once on Day 1.

Drug: TAK-137

Cohort 3: TAK-137 10 mg

EXPERIMENTAL

TAK-137 10 mg, tablets, orally, once on Day 1.

Drug: TAK-137

Cohort 4: TAK-137 5 mg Food Effect

EXPERIMENTAL

TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2.

Drug: TAK-137

Cohort 5: TAK-137 0.5 mg

EXPERIMENTAL

TAK-137 0.5 mg, tablets, orally, once on Day 1.

Drug: TAK-137

Cohort 6: TAK-137 20 mg

EXPERIMENTAL

TAK-137 20 mg, tablets, orally, once on Day 1.

Drug: TAK-137

Cohorts 1-6: Placebo

PLACEBO COMPARATOR

TAK-137 placebo-matching tablets, orally, once on Day 1.

Drug: Placebo

Interventions

TAK-137 DRUG

TAK-137 tablets

Cohort 1: TAK-137 2 mg; Cohort 2: TAK-137 5 mg; Cohort 3: TAK-137 10 mg; Cohort 4: TAK-137 5 mg Food Effect; Cohort 5: TAK-137 0.5 mg; Cohort 6: TAK-137 20 mg

Placebo DRUG

TAK-137 placebo-matching tablets

Cohorts 1-6: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is a healthy male or non-pregnant, non-lactating female adult who is 18 to 55 years of age inclusive at the time of informed consent and first study medication dose.
• Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m\^2, inclusive at Screening.
• Is able to comply with the protocol and is willing to sign the informed consent prior to undergoing any study-related procedures.

You may not qualify if:

• Has a known hypersensitivity to any component of the formulation of TAK-137.
• Has a medical condition such as mental retardation that can cause cognitive impairment.
• Has a risk of suicide according to the Investigator's clinical judgment (eg, per Columbia-Suicide Severity Rating Scale \[C-SSRS\] or has made a suicide attempt in the previous 6 months).
• 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 participant's medical history, physical examination, or safety laboratory tests (including safety electroencephalogram \[EEG\]) giving reasonable suspicion of a disease that would contraindicate taking TAK-137, 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 taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Interventions

TAK-137

Results Point of Contact

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

clinicaltrialregistry@tpna.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: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 9, 2015
• Study Start: June 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 10, 2015
• Results First Posted: February 10, 2015

Record last verified: 2015-01