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

NCT03609775 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-10-15

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

ACT-541468

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

OTHER

ACT-541468 placebo

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

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.

OTHER

Ethanol placebo

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

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Pascale Gasser · Idorsia Pharmaceuticals Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2018-10-09
Completion
2018-10-09
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03609775 on ClinicalTrials.gov