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

October 12, 2018 updated by: Idorsia Pharmaceuticals Ltd.

A Double-blind, Randomized, Placebo-controlled, Double-dummy, Four-way Crossover Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leiden, Netherlands, 2333
        • Centre For Human Drug Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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)
Drug: ACT-541468
One tablet of 50 mg ACT-541468 will be administered orally.
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.
Experimental: Treatment B (ethanol placebo + ACT-541468)
5 h i.v. placebo clamp in combination with a single oral dose of ACT-541468 (50 mg)
Drug: ACT-541468
One tablet of 50 mg ACT-541468 will be administered orally.
Other: Ethanol placebo
Matching placebo for the ethanol infusion (i.e., 5% glucose solution) will be administered i.v. for 5 h.
Experimental: 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
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: ACT-541468 placebo
Matching ACT-541468 placebo will be administered orally as 1 tablet.
Experimental: 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
Other: Ethanol placebo
Matching placebo for the ethanol infusion (i.e., 5% glucose solution) will be administered i.v. for 5 h.
Other: ACT-541468 placebo
Matching ACT-541468 placebo will be administered orally as 1 tablet.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline for saccadic peak velocity (degrees/sec) to assess sedation
Time Frame: Several timepoints on Day 1; for up to 24 hours post-dose
Several timepoints on Day 1; for up to 24 hours post-dose

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline for smooth pursuit (%) to assess eye movement coordination and attention
Time Frame: Several timepoints on Day 1; for up to 24 hours post-dose
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
Time Frame: Several timepoints on Day 1; for up to 24 hours post-dose
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
Time Frame: Several timepoints on Day 1; for up to 24 hours post-dose
Several timepoints on Day 1; for up to 24 hours post-dose
Change from baseline for visual analog scales (VAS) Bond & Lader to assess subjective alertness, mood, and calmness
Time Frame: Several timepoints on Day 1; for up to 24 hours post-dose
Several timepoints on Day 1; for up to 24 hours post-dose
Change from baseline for VAS for alcohol intoxication to assess subjective effects of ethanol
Time Frame: Several timepoints on Day 1; for up to 24 hours post-dose
Several timepoints on Day 1; for up to 24 hours post-dose
ACT-541468 PK endpoints for treatments A and B: Area under the plasma concentration-time curve (AUC) from time zero to 24 h (AUC0-24)
Time Frame: Several timepoints from Day 1 to Day 2 (EOT/EOS); for up to 24 hours post-dose
Several timepoints from Day 1 to Day 2 (EOT/EOS); for up to 24 hours post-dose
ACT-541468 PK endpoints for treatments A and B: AUC from zero to infinity (AUC0-∞)
Time Frame: Several timepoints from Day 1 to Day 2 (EOT/EOS); for up to 24 hours post-dose
Several timepoints from Day 1 to Day 2 (EOT/EOS); for up to 24 hours post-dose
ACT-541468 PK endpoints for treatments A and B: Maximum plasma concentration (Cmax)
Time Frame: Several timepoints from Day 1 to Day 2 (EOT/EOS); for up to 24 hours post-dose
Several timepoints from Day 1 to Day 2 (EOT/EOS); for up to 24 hours post-dose
ACT-541468 PK endpoints for treatments A and B: Time to reach Cmax (tmax)
Time Frame: Several timepoints from Day 1 to Day 2 (EOT/EOS); for up to 24 hours post-dose
Several timepoints from Day 1 to Day 2 (EOT/EOS); for up to 24 hours post-dose
ACT-541468 PK endpoints for treatments A and B: Terminal elimination half-life (t½)
Time Frame: Several timepoints from Day 1 to Day 2 (EOT/EOS); for up to 24 hours post-dose
Several timepoints from Day 1 to Day 2 (EOT/EOS); for up to 24 hours post-dose
Ethanol PK endpoints for treatments A and C: Breath ethanol concentrations (BrEC)
Time Frame: Several timepoints on Day 1; for up to 24 hours post-dose
Several timepoints on Day 1; for up to 24 hours post-dose
Ethanol PK endpoints for treatments A and C: Total ethanol dose (in grams) required to maintain the 0.6 g/L ethanol clamp
Time Frame: Several timepoints on Day 1; for up to 5 hours
Several timepoints on Day 1; for up to 5 hours
Safety endpoints: Treatment-emergent AEs from study treatment administration up to EOT in each treatment period
Time Frame: AEs from Day 1 to Day 2 (EOT/EOS); for up to 2 days post-dose
AEs from Day 1 to Day 2 (EOT/EOS); for up to 2 days post-dose
Safety endpoints: Treatment-emergent SAEs from study treatment administration up to EOT in each treatment period
Time Frame: SAEs from Screening to Safety follow up; for up to 14 weeks
SAEs from Screening to Safety follow up; for up to 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Idorsia Pharmaceuticals Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pascale Gasser, Idorsia Pharmaceuticals Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ID-078-111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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