NCT03609775

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

August 28, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1 month

First QC Date

July 25, 2018

Last Update Submit

October 12, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline for saccadic peak velocity (degrees/sec) to assess sedation

    Several timepoints on Day 1; for up to 24 hours post-dose

Other Outcomes (14)

  • Change from baseline for smooth pursuit (%) to assess eye movement coordination and attention

    Several timepoints on Day 1; for up to 24 hours post-dose

  • Change from baseline for adaptive tracking (%) to assess visuo-motor control and vigilance

    Several timepoints on Day 1; for up to 24 hours post-dose

  • Change from baseline for body sway (antero-posterior in mm / 2 min) to assess postural stability

    Several timepoints on Day 1; for up to 24 hours post-dose

  • +11 more other outcomes

Study Arms (4)

Treatment A (ethanol + ACT-541468)

EXPERIMENTAL

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)

Drug: ACT-541468Other: Ethanol 10%

Treatment B (ethanol placebo + ACT-541468)

EXPERIMENTAL

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

Drug: ACT-541468Other: Ethanol placebo

Treatment C (ethanol + ACT-541468 placebo)

EXPERIMENTAL

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

Other: ACT-541468 placeboOther: Ethanol 10%

Treatment D (ethanol placebo + ACT-541468 placebo)

EXPERIMENTAL

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

Other: ACT-541468 placeboOther: Ethanol placebo

Interventions

ACT-541468DRUG

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

Treatment A (ethanol + ACT-541468)Treatment B (ethanol placebo + ACT-541468)
ACT-541468 placeboOTHER

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

Treatment C (ethanol + ACT-541468 placebo)Treatment D (ethanol placebo + ACT-541468 placebo)
Ethanol 10%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 A (ethanol + ACT-541468)Treatment C (ethanol + ACT-541468 placebo)
Ethanol placeboOTHER

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

Treatment B (ethanol placebo + ACT-541468)Treatment D (ethanol placebo + ACT-541468 placebo)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre For Human Drug Research

Leiden, 2333, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 33205362DERIVED

MeSH Terms

Interventions

daridorexantethanol lumiflavine

Study Officials

  • Pascale Gasser

    Idorsia Pharmaceuticals Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Double-dummy, four-way crossover study design
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 1, 2018

Study Start

August 28, 2018

Primary Completion

October 9, 2018

Study Completion

October 9, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)