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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101189
• Other study ID #: AC-078-105
• Status: Completed
• Phase: Phase 1
• Start date: March 15, 2017
• Est. completion date: April 26, 2017

Study information

• Verified date: July 2018
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 26, 2017
• Est. primary completion date: April 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• ACT-541468
Capsule
• placebo
Matching placebo capsule

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of ACT-541468	The geometric mean Cmax values will be calculated based on pharmacokinetic (PK) blood sampling	From Day1 pre-dose to 48 hours after the last dose on Day 5
Primary	Area under the plasma concentration-time curves during a dosing interval [AUC(0-24)] of ACT-541468	The geometric mean AUC(0-24) values will be calculated based on PK blood sampling	From Day1 pre-dose to 48 hours after the last dose on Day 5
Secondary	Time to reach Cmax (tmax) of ACT-541468	The median tmax values will be calculated based on PK blood sampling	From Day1 pre-dose to 48 hours after the last dose on Day 5
Secondary	Terminal half-life [t(1/2)] of ACT-541468	The geometric mean t(1/2) values will be calculated based on PK blood sampling	From Day1 pre-dose to 48 hours after the last dose on Day 5
Secondary	Area under the plasma concentration-time curves from time 0 to 8 h [AUC(0-8)]	The geometric mean AUC(0-8) values will be calculated based on PK blood sampling	From Day1 pre-dose to 48 hours after the last dose on Day 5
Secondary	Incidence of treatment-emergent adverse events	The percentage of subjects with treatment-emergent adverse events will be reported	Up to Day 7 (end of study)
Secondary	Incidence of adverse events leading to premature discontinuation of study treatment	The number of subjects who prematurely discontinued the study treatment due to an adverse event will be reported	Up to Day 5
Secondary	Incidence of any clinical relevant findings in ECG variables	The number of subjects with any treatment-emergent electrocardiogram (ECG) abnormalities will be reported	Up to Day 7 (end of study)