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Completed

NCT Number: NCT03101189

A Study of ACT-541468 in Healthy Japanese and Caucasian Subjects

So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will bridge results obtained in Caucasian subjects to those in Japanese subjects.

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Human Drug Research

Leiden, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Signed informed consent form;
  • Healthy male and female subjects aged between 20 and 50 years (inclusive) at screening;
  • Negative serum pregnancy tests at screening and negative urine pregnancy test at Day 1 for women of childbearing potential and agreement to use a reliable method of contraception for at least 90 days after last study drug intake;
  • Body mass index (BMI) of 18.0 to 26.0 kg/m2 (inclusive) at screening;
  • Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests;
  • Caucasian or Japanese ethnicity.

Japanese subjects only:

  • must be of native Japanese descent (all parents/grandparents of Japanese descent);
  • must not have been away from Japan for more than 10 years (at screening visit);
  • lifestyle should not have changed significantly since relocation from Japan.

Key Exclusion Criteria:

  • Any contraindication to the study treatments;
  • History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments;
  • History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score < 0;
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Treatment and study plan

ACT-541468

Drug

Capsule

Placebo

Drug

Matching placebo capsule

Primary outcomes

  1. Maximum plasma concentration (Cmax) of ACT-541468

    Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5

    The geometric mean Cmax values will be calculated based on pharmacokinetic (PK) blood sampling

  2. Area under the plasma concentration-time curves during a dosing interval [AUC(0-24)] of ACT-541468

    Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5

    The geometric mean AUC(0-24) values will be calculated based on PK blood sampling

Secondary outcomes

  1. Time to reach Cmax (tmax) of ACT-541468

    Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5

    The median tmax values will be calculated based on PK blood sampling

  2. Terminal half-life [t(1/2)] of ACT-541468

    Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5

    The geometric mean t(1/2) values will be calculated based on PK blood sampling

  3. Area under the plasma concentration-time curves from time 0 to 8 h [AUC(0-8)]

    Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5

    The geometric mean AUC(0-8) values will be calculated based on PK blood sampling

  4. Incidence of treatment-emergent adverse events

    Time frame: Up to Day 7 (end of study)

    The percentage of subjects with treatment-emergent adverse events will be reported

  5. Incidence of adverse events leading to premature discontinuation of study treatment

    Time frame: Up to Day 5

    The number of subjects who prematurely discontinued the study treatment due to an adverse event will be reported

  6. Incidence of any clinical relevant findings in ECG variables

    Time frame: Up to Day 7 (end of study)

    The number of subjects with any treatment-emergent electrocardiogram (ECG) abnormalities will be reported

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study title

A Single-center, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-dose ACT-541468 in Healthy Japanese and Caucasian Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2017
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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