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

NCT ID: NCT03609775

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-28
• Study Completion Date: 2018-10-09

Brief Summary

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

Conditions

Healthy

Study Design

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

Study Groups

Treatment A (ethanol + 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)

Group Type: EXPERIMENTAL

ACT-541468

Intervention Type: DRUG

One tablet of 50 mg ACT-541468 will be administered orally.

Ethanol 10%

Intervention Type: OTHER

Ethanol 10% w/v solution in 5% glucose will be administered i.v. for 5 h and clamped at an ethanol level of 0.6 g/L.

Treatment B (ethanol placebo + ACT-541468)

5 h i.v. placebo clamp in combination with a single oral dose of ACT-541468 (50 mg)

Group Type: EXPERIMENTAL

ACT-541468

Intervention Type: DRUG

One tablet of 50 mg ACT-541468 will be administered orally.

Ethanol placebo

Intervention Type: OTHER

Matching placebo for the ethanol infusion (i.e., 5% glucose solution) will be administered i.v. for 5 h.

Treatment C (ethanol + 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

Group Type: EXPERIMENTAL

ACT-541468 placebo

Intervention Type: OTHER

Matching ACT-541468 placebo will be administered orally as 1 tablet.

Ethanol 10%

Intervention Type: OTHER

Ethanol 10% w/v solution in 5% glucose will be administered i.v. for 5 h and clamped at an ethanol level of 0.6 g/L.

Treatment D (ethanol placebo + ACT-541468 placebo)

5 h i.v. placebo clamp in combination with a single oral dose of matching ACT-541468 placebo

Group Type: EXPERIMENTAL

ACT-541468 placebo

Intervention Type: OTHER

Matching ACT-541468 placebo will be administered orally as 1 tablet.

Ethanol placebo

Intervention Type: OTHER

Matching placebo for the ethanol infusion (i.e., 5% glucose solution) will be administered i.v. for 5 h.

Interventions

ACT-541468

One tablet of 50 mg ACT-541468 will be administered orally.

Intervention Type: DRUG

ACT-541468 placebo

Matching ACT-541468 placebo will be administered orally as 1 tablet.

Intervention Type: OTHER

Ethanol 10%

Ethanol 10% w/v solution in 5% glucose will be administered i.v. for 5 h and clamped at an ethanol level of 0.6 g/L.

Intervention Type: OTHER

Ethanol placebo

Matching placebo for the ethanol infusion (i.e., 5% glucose solution) will be administered i.v. for 5 h.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascale Gasser

Role: STUDY_DIRECTOR

Idorsia Pharmaceuticals Ltd.

Locations

Centre For Human Drug Research

Leiden, , Netherlands

Countries

Netherlands

References

Berger B, Brooks S, Zuiker R, Richard M, Muehlan C, Dingemanse J. Pharmacological Interactions between the Dual Orexin Receptor Antagonist Daridorexant and Ethanol in a Double-Blind, Randomized, Placebo-Controlled, Double-Dummy, Four-Way Crossover Phase I Study in Healthy Subjects. CNS Drugs. 2020 Dec;34(12):1253-1266. doi: 10.1007/s40263-020-00768-8. Epub 2020 Nov 18.

Reference Type: DERIVED

PMID: 33205362 (View on PubMed)

Other Identifiers

ID-078-111

Identifier Type: -

Identifier Source: org_study_id