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

NCT04551079 | Completed Phase 1 FDA Drug

• 2 other identifiers: TAK-994-1503U1111-1256-7132
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (5)

• Number of Participants who Experience at Least 1 Treatment Emergent Adverse Event (TEAE) During the Study

  From first dose of the study drug up to Day 7 after the last dose of study drug on Day 2 in Treatment Period 3 (up to Day 27)

• Number of Participants who Meet the Markedly Abnormal Value for Safety Laboratory Tests at Least Once Postdose During the Study

  From first dose of the study drug up to Day 7 after the last dose of study drug on Day 2 in Treatment Period 3 (up to Day 27)

• Number of Participants who Meet the Markedly Abnormal Value for Vital Sign Measurements at Least Once Postdose During the Study

  From first dose of the study drug up to Day 7 after the last dose of study drug on Day 2 in Treatment Period 3 (up to Day 27)

• Number of Participants who Meet the Markedly Abnormal Value for Safety Electrocardiogram (ECG) Parameters at Least Once Postdose During the Study

  From first dose of the study drug up to Day 7 after the last dose of study drug on Day 2 in Treatment Period 3 (up to Day 27)

• Mean Sleep Latency Over Four Maintenance of Wakefulness Test (MWT) Sessions After Initial Dosing

  MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Tendency to fall asleep is measured via electroencephalography-derived sleep latency. Mean sleep latency: mean time to sleep onset, over 4 MWT sessions (at approximately 2, 4, 6, and 8 hours after initial dosing).

  Up to 8 hours after initial dosing in each treatment period

Secondary Outcomes (4)

• Cmax: Maximum Observed Plasma Concentration for TAK-994

  Days 1 and 2: Pre-dose and at multiple time points (up to 10 hours) post-dose

• Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-994

  Days 1 and 2: Pre-dose and at multiple time points (up to 10 hours) post-dose

• AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-994

  Days 1 and 2: Pre-dose and at multiple time points (up to 10 hours) post-dose

• Change From Baseline in Mean Karolinska Sleepiness Scale (KSS) Score

  Baseline up to 8.75 hours after initial dosing in each treatment period

Study Arms (3)

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

EXPERIMENTAL

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.

Drug: TAK-994; Drug: Placebo

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

EXPERIMENTAL

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.

Drug: TAK-994; Drug: Placebo

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

EXPERIMENTAL

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.

Drug: TAK-994

Interventions

TAK-994 DRUG

TAK-994 tablets.

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

Placebo DRUG

TAK-994 placebo-matching tablets.

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.
• 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.
• At the time of screening, be receiving treatment with nasal/oronasal positive airway pressure for any reason.
• Have abnormal findings on the initial polysomnography conducted on Day -1 (check-in) of the first treatment period.
• Have traveled across 2 or more time zones within the 2 weeks before screening.
• 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).

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Clinilabs Drug Development Corporation

New York, New York, 10019, United States

Location

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 16, 2020
• Study Start: September 23, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)