A Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: ACT-541468 placebo; Drug: ACT-541468; Other: Ethanol placebo; Other: Ethanol 10%

• Registration Number: NCT03609775
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

Brief Summary

A study to investigate the drug-drug interactions between ACT-541468 and ethanol in healthy subjects

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-07-25
• Study First Posted: 2018-08-01
• Study Start: 2018-08-28
• Status Verified: 2018-10
• Primary Completion: 2018-10-09
• Study Completion: 2018-10-09
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Signed informed consent prior to any study-mandated procedure.
• Healthy male and female subjects aged between 18 and 45 years (inclusive) at screening.
• Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 pre-dose of each treatment period. They must consistently and correctly use a reliable method of contraception, be sexually inactive, or have a vasectomized partner.
• Women of non-childbearing potential (i.e., postmenopausal).
• Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening.
• Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests.
• Previous experience with alcohol consumption and, therefore, familiar with the effects of alcohol.

Exclusion Criteria

• Pregnant or lactating women.
• Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
• Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.
• Nicotine intake within 3 months prior to screening and inability to refrain from nicotine intake from screening until End-of-Study (EOS).
• Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks prior to first study treatment administration.
• History or clinical evidence of alcoholism or drug abuse.
• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of more than 21 units or an average daily intake of more than 3 units (males), or defined as an average weekly intake of more than 14 units or an average daily intake of more than 2 units (females).
• Individuals of Asian descent or other individuals reporting ethanol intolerance.
• Modified Swiss Narcolepsy Scale total score < 0 at screening or history of narcolepsy or cataplexy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment D (ethanol placebo + ACT-541468 placebo)	ACT-541468 placebo	5 h i.v. placebo clamp in combination with a single oral dose of matching ACT-541468 placebo
Treatment C (ethanol + ACT-541468 placebo)	ACT-541468 placebo	5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of matching ACT-541468 placebo
Treatment D (ethanol placebo + ACT-541468 placebo)	Ethanol placebo	5 h i.v. placebo clamp in combination with a single oral dose of matching ACT-541468 placebo
Treatment B (ethanol placebo + ACT-541468)	Ethanol placebo	5 h i.v. placebo clamp in combination with a single oral dose of ACT-541468 (50 mg)
Treatment C (ethanol + ACT-541468 placebo)	Ethanol 10%	5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of matching ACT-541468 placebo
Treatment A (ethanol + ACT-541468)	Ethanol 10%	5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of ACT-541468 (50 mg)
Treatment A (ethanol + ACT-541468)	ACT-541468	5 h i.v. ethanol clamp at a level of 0.6 g/L in combination with a single oral dose of ACT-541468 (50 mg)
Treatment B (ethanol placebo + ACT-541468)	ACT-541468	5 h i.v. placebo clamp in combination with a single oral dose of ACT-541468 (50 mg)

Primary Outcome Measures

Name	Time	Method
Change from baseline for saccadic peak velocity (degrees/sec) to assess sedation	Several timepoints on Day 1; for up to 24 hours post-dose

Trial Locations

Locations (1)

Centre For Human Drug Research; 🇳🇱 Leiden, Netherlands