A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults

NCT ID: NCT03522506

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-09
• Study Completion Date: 2018-11-07

Brief Summary

The purpose of this study is to determine the effect of TAK-925 after a single intravenous dose (compared to placebo) on promoting wakefulness as measured by sleep latency on the maintenance of wakefulness (MWT) in sleep-deprived healthy participants.

Detailed Description

The drug being tested in this study is called TAK-925. This study will assess the safety, tolerability, PK and PD of TAK-925 and will assess the effects of TAK-925 in sleep-deprived healthy adult participants.

The study will enroll approximately 20 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 4 treatment sequences-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

• TAK-925 Low Dose + Placebo + TAK-925 High Dose + Modafinil
• TAK-925 High Dose + TAK-925 Low Dose + Modafinil + Placebo
• Modafinil+ TAK-925 High Dose + Placebo + TAK-925 Low Dose
• Placebo + Modafinil + TAK-925 Low Dose + TAK-925 High Dose

TAK-925 will be administered as an intravenous infusion based on the availability of safety, tolerability and PK data from health Japanese participants in ongoing study TAK-925-1001.

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 make a final visit 7 days after receiving their last dose of drug for a follow-up assessment.

Conditions

Healthy Volunteers

Study Design

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

Study Groups

TAK-925 Low Dose + Placebo + TAK-925 High Dose + Modafinil

TAK-925 low dose milligram (mg), intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 1, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Intervention Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 high dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 3, followed by a minimum of 7-days washout period, further followed by Modafinil 300 mg, tablet, orally, once on Day 1 of Intervention Period 4. TAK-925 dose will be decided based on the availability of safety, tolerability and PK data from ongoing study TAK-925-1001.

Group Type: EXPERIMENTAL

TAK-925

Intervention Type: DRUG

TAK-925 intravenous infusion.

TAK-925 Placebo

Intervention Type: DRUG

TAK-925 placebo-matching given as saline intravenous infusion.

Modafinil

Intervention Type: DRUG

Modafinil tablets.

Modafinil Placebo

Intervention Type: DRUG

Modafinil placebo-matching tablet.

TAK-925 High Dose + TAK-925 Low Dose + Modafinil + Placebo

TAK-925 high dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 low dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 2, followed by a minimum of 7-days washout period, further followed by Modafinil 300 mg, tablet, orally, once on Day 1 of Intervention Period 3, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Intervention Period 4. TAK-925 dose will be decided based on the availability of safety, tolerability and PK data from ongoing study TAK-925-1001.

Group Type: EXPERIMENTAL

TAK-925

Intervention Type: DRUG

TAK-925 intravenous infusion.

TAK-925 Placebo

Intervention Type: DRUG

TAK-925 placebo-matching given as saline intravenous infusion.

Modafinil

Intervention Type: DRUG

Modafinil tablets.

Modafinil Placebo

Intervention Type: DRUG

Modafinil placebo-matching tablet.

Modafinil + TAK-925 High Dose + Placebo + TAK-925 Low Dose

Modafinil 300 mg, tablet, orally, once on Day 1 of Intervention Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 high dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 2, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Intervention Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 low dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 4. TAK-925 dose will be decided based on the availability of safety, tolerability and PK data from ongoing study TAK-925-1001.

Group Type: EXPERIMENTAL

TAK-925

Intervention Type: DRUG

TAK-925 intravenous infusion.

TAK-925 Placebo

Intervention Type: DRUG

TAK-925 placebo-matching given as saline intravenous infusion.

Modafinil

Intervention Type: DRUG

Modafinil tablets.

Modafinil Placebo

Intervention Type: DRUG

Modafinil placebo-matching tablet.

Placebo + Modafinil + TAK-925 Low Dose + TAK-925 High Dose

Placebo, once on Day 1 of Intervention Period 1, followed by a minimum of 7-days washout period, further followed by Modafinil 300 mg, tablet, orally, once on Day 1 of Intervention Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 low dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 high dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 4. TAK-925 dose will be decided based on the availability of safety, tolerability and PK data from ongoing study TAK-925-1001.

Group Type: EXPERIMENTAL

TAK-925

Intervention Type: DRUG

TAK-925 intravenous infusion.

TAK-925 Placebo

Intervention Type: DRUG

TAK-925 placebo-matching given as saline intravenous infusion.

Modafinil

Intervention Type: DRUG

Modafinil tablets.

Modafinil Placebo

Intervention Type: DRUG

Modafinil placebo-matching tablet.

Interventions

TAK-925

TAK-925 intravenous infusion.

Intervention Type: DRUG

TAK-925 Placebo

TAK-925 placebo-matching given as saline intravenous infusion.

Intervention Type: DRUG

Modafinil

Modafinil tablets.

Intervention Type: DRUG

Modafinil Placebo

Modafinil placebo-matching tablet.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

3. Be willing to have actigraphy monitoring during the week before randomization and in each interval.

Exclusion Criteria

1. Has a positive alcohol or drug screen.

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

3. Has excessive sleepiness defined by a self-reported Epworth Sleepiness Scale score at screening greater than 10; irregular work hours; or routine night-shift work within 1 month before randomization.

4. Currently experiencing or having a history of any known/suspected sleep disorder, any disorder associated with excessive daytime somnolence (EDS), or any diagnosis interfering with assessment of sleepiness.

5. Abnormal findings on the initial polysomnography (PSG) conducted on Day -1 (check-in), as specified in the study manual.

6. Traveled across 2 or more time zones 2 weeks or less before screening.

7. Caffeine consumption of more than 400 milligram per day (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

PRA Health Sciences

Salt Lake City, Utah, United States

Countries

United States

References

Evans R, Kimura H, Nakashima M, Ishikawa T, Yukitake H, Suzuki M, Hazel J, Faessel H, Wu J, Hang Y, Alexander R, Rosen L, Hartman DS, Ratti E. Orexin 2 receptor-selective agonist danavorexton (TAK-925) promotes wakefulness in non-human primates and healthy individuals. J Sleep Res. 2023 Oct;32(5):e13878. doi: 10.1111/jsr.13878. Epub 2023 Mar 19.

Reference Type: DERIVED

PMID: 36934366 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1211-2133

Identifier Type: OTHER

Identifier Source: secondary_id

TAK-925-1002

Identifier Type: -

Identifier Source: org_study_id