A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics (PK) of Oral TAK-994 in an Acute Sleep Phase Delay Paradigm in Healthy Male Participants

NCT ID: NCT04551079

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-23
• Study Completion Date: 2020-12-31

Brief Summary

The purpose of this study is to assess the safety and tolerability of TAK-994 and to determine the effect of TAK-994 (compared to placebo) on sleepiness, as measured by mean sleep latency on the maintenance of wakefulness Test (MWT), in an acute sleep phase delay paradigm in healthy participants.

Detailed Description

The drug being tested in this study is called TAK-994. The study will evaluate the safety/tolerability, PD, and PK of TAK-994 in an acute sleep phase delay paradigm in healthy participants.

The study will enroll up to approximately 18 healthy participants. Participants will be randomly assigned to 1 of the 3 treatment sequences which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

• TAK-994 Dose A + Placebo + TAK-994 Dose B
• TAK-994 Dose B + TAK-994 Dose A + Placebo
• Placebo + TAK-994 Dose B + TAK-994 Dose A

This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 10 weeks. Participants will be followed up remotely on Day 7 after the last dose of study drug for a follow-up assessment.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

TAK-994 Dose A+ Placebo + TAK-994 Dose B

TAK-994 Dose A tablets, orally, on Days 1 and 2 of Treatment Period 1, followed by TAK-994 placebo-matching tablets, orally, on Days 1 and 2 of Treatment Period 2, further followed by TAK-994 Dose B tablets, orally, on Days 1 and 2 of Treatment Period 3. A Washout Period of at least 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

TAK-994

Intervention Type: DRUG

TAK-994 tablets.

Placebo

Intervention Type: DRUG

TAK-994 placebo-matching tablets.

TAK-994 Dose B + TAK-994 Dose A + Placebo

TAK-994 Dose B tablets, orally, on Days 1 and 2 of Treatment Period 1, followed by TAK-994 Dose A tablets, orally, on Days 1 and 2 of Treatment Period 2, further followed by TAK-994 placebo-matching tablets, orally, on Days 1 and 2 of Treatment Period 3. A Washout Period of at least 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

TAK-994

Intervention Type: DRUG

TAK-994 tablets.

Placebo

Intervention Type: DRUG

TAK-994 placebo-matching tablets.

Placebo + TAK-994 Dose B+ TAK-994 Dose A

TAK-994 placebo-matching tablets, orally, on Days 1 and 2 of Treatment Period 1, followed by TAK-994 Dose B tablets orally, on Days 1 and 2 of Treatment Period 2, further followed by TAK-994 Dose A tablets, orally, on Days 1 and 2 of Treatment Period 3. A Washout Period of at least 7 days will be maintained between each treatment period.

Group Type: EXPERIMENTAL

TAK-994

Intervention Type: DRUG

TAK-994 tablets.

Interventions

TAK-994

TAK-994 tablets.

Intervention Type: DRUG

Placebo

TAK-994 placebo-matching tablets.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Be a current nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months prior to the first dose of study drug.

2. Have regular sleep-wake habits (example, routinely spending 6.5 to 8 hour sleeping nightly, not oversleeping by more than 3 hour on weekends [that is, total sleep not more than 11 hour]) as determined by investigator interviews and confirmed in 5-day actigraphy records and regularly fall asleep between 9:30 PM and 12:00 AM.

Exclusion Criteria

1. Have a positive alcohol or drug screen or a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce] per day).

2. Have excessive sleepiness, defined by a self-reported Epworth Sleepiness Scale (ESS) score at screening greater than (>) 10; irregular work hours; or routine night-shift work within 1 month before randomization.

3. Have a prior history of or currently is experiencing any known/suspected sleep disorder (including obstructive sleep apnea and restless leg syndrome), any disorder associated with excessive daytime sleepiness (EDS), or any diagnosis interfering with assessment of sleepiness.

4. At the time of screening, be receiving treatment with nasal/oronasal positive airway pressure for any reason.

5. Have abnormal findings on the initial polysomnography conducted on Day -1 (check-in) of the first treatment period.

6. Have traveled across 2 or more time zones within the 2 weeks before screening.

7. Have caffeine consumption of more than 400 milligram (mg)/day for 2 weeks before screening (1 serving of coffee is approximately equivalent to 120 mg of caffeine).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

Clinilabs Drug Development Corporation

New York, New York, United States

Countries

United States

Other Identifiers

U1111-1256-7132

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-994-1503

Identifier Type: -

Identifier Source: org_study_id