Status:
COMPLETED
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ACT-1004-1239 in Healthy Male Subjects
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This Phase 1 study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of ACT-1004-1239 in healthy subjects.
Eligibility Criteria
Inclusion
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- Healthy male subjects aged between 18 and 55 years (inclusive) at Screening.
- No sperm donation from (first) study treatment administration up to at least 90 days after (last) study treatment administration.
- Sexual abstinence or use of condoms from (first) treatment administration up to at least 90 days after (last) study treatment administration. Moreover, the female partner of childbearing potential must use a highly effective method of contraception.
Exclusion
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Any previous and/or ongoing relevant immune-related disorder or any evidence for immune dysfunction based on medical history and laboratory tests at Screening
- Any cardiac condition or illness (including clinically relevant 12-lead ECG abnormalities) with a potential to increase the cardiac risk of the subject based on medical history and 12-lead ECG measured at Screening.
- QT interval corrected with Fridericia's formula (QTcF) \> 430 ms, respectively, QRS interval \> 110 ms, PR interval \> 200 ms, or heart rate (HR) \> 90 bpm on 12-lead ECG at Screening and Day 1 pre-dose (of the first period when applicable).
- Treatment with another investigational treatment within the 2 months prior to Screening or participation in more than 3 investigational treatment studies within the year prior to Screening.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the ADME of the study treatment (e.g., appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Previous treatment with any prescribed medications (including vaccines and strong CYP3A4 inhibitors/inducers) or over-the-counter (OTC) medications (including homeopathic preparations, herbal medicines, vitamins, and minerals) within the 2 weeks or 5 terminal half-lives (t½; whichever is longer) prior to (first) study treatment administration.
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2019
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03869320
Start Date
March 25 2019
End Date
July 11 2019
Last Update
January 10 2020
Active Locations (1)
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1
Pharmaron CPC, Inc. & Affiliates
Baltimore, Maryland, United States, 21201