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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03101189
Recruitment Status : Completed
First Posted : April 5, 2017
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: ACT-541468 Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official 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
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : April 24, 2017
Actual Study Completion Date : April 26, 2017

Arm Intervention/treatment
Experimental: ACT-541468 (25 mg)
8 Japanese and 8 Caucasian subjects will receive 25 mg (1 capsule) of ACT-541468 once daily for 5 days
Drug: ACT-541468
Capsule

Experimental: ACT-541468 (50 mg)
8 Japanese and 8 Caucasian subjects will receive 50 mg (2 capsules) of ACT-541468 once daily for 5 days
Drug: ACT-541468
Capsule

Placebo Comparator: Placebo
2 Japanese / 2 Caucasian subjects will receive 1 placebo capsule to match subjects in the ACT-541468 (25 mg) group and 2 other Japanese / 2 Caucasian subjects will receive 2 placebo capsules to match subjects in the ACT-541468 (50 mg) group
Drug: placebo
Matching placebo capsule




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101189


Locations
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Netherlands
Centre for Human Drug Research
Leiden, Netherlands
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Clemens Muehlan Actelion

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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03101189     History of Changes
Other Study ID Numbers: AC-078-105
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Idorsia Pharmaceuticals Ltd.:
safety
Japanese
pharmacokinetics