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

NCT ID: NCT02334982

Last Updated: 2015-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-01-31

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.

Detailed Description

The drug being tested in this study is called TAK-137. TAK-137 is being tested to find a safe and well-tolerated dose. This study looked at safety (lab results and side effects) and pharmacokinetic properties (drug absorption, distribution, metabolism, and excretion) in people who took TAK-137. This study was designed as a single ascending 6 Cohort dose study with planned doses of 2, 5, 15, 50, and 100 mg and Cohort 6 dose to be determined if the maximum tolerated dose (MTD) was not reached. Anticipated enrollment was 48.

This study enrolled 47 participants and consisted of 6 Cohorts. Participants in Cohorts 1, 2, 3, 5 and 6 were randomized to receive a single dose of TAK-137 or placebo after a 10-hour fast. Participants in Cohort 4 were randomized to receive a single dose of TAK-137 or placebo under fasted conditions, followed by a single dose of TAK-137 or placebo under fed conditions 14 days later. Participants in cohort 4 will receive the same dose in both fasted and fed conditions. The starting dose was 2 mg followed by administrations of 5, 10, 0.5 and 20 mg.

This single-center trial was conducted in the United States. For Cohorts 1, 2, 3, 5, and 6 the overall time to participate in this study was up to 42 days. Participants made 4 visits to the clinic including one 5-day period of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

For Cohort 4 the overall time to participate in this study was up to 56 days. Participants made 7 visits to the clinic including two 5-day periods of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Conditions

Dose Finding Study

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1: TAK-137 2 mg

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

Group Type: EXPERIMENTAL

TAK-137

Intervention Type: DRUG

TAK-137 tablets

Cohort 2: TAK-137 5 mg

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

Group Type: EXPERIMENTAL

TAK-137

Intervention Type: DRUG

TAK-137 tablets

Cohort 3: TAK-137 10 mg

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

Group Type: EXPERIMENTAL

TAK-137

Intervention Type: DRUG

TAK-137 tablets

Cohort 4: TAK-137 5 mg Food Effect

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.

Group Type: EXPERIMENTAL

TAK-137

Intervention Type: DRUG

TAK-137 tablets

Cohort 5: TAK-137 0.5 mg

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

Group Type: EXPERIMENTAL

TAK-137

Intervention Type: DRUG

TAK-137 tablets

Cohort 6: TAK-137 20 mg

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

Group Type: EXPERIMENTAL

TAK-137

Intervention Type: DRUG

TAK-137 tablets

Cohorts 1-6: Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

TAK-137 placebo-matching tablets

Interventions

TAK-137

TAK-137 tablets

Intervention Type: DRUG

Placebo

TAK-137 placebo-matching tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Weighs at least 45 kg and has a body mass index (BMI) between 18 and 30.0 kg/m^2, inclusive at Screening.

3. Is able to comply with the protocol and is willing to sign the informed consent prior to undergoing any study-related procedures.

Exclusion Criteria

1. Has a known hypersensitivity to any component of the formulation of TAK-137.

2. Has a medical condition such as mental retardation that can cause cognitive impairment.

3. 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).

4. 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.

5. 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.

6. Has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Other Identifiers

U1111-1164-7376

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-137_101

Identifier Type: -

Identifier Source: org_study_id