A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ACT-1004-1239 in Healthy Male Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ACT-1004-1239 ACT-1004-1239 will be given as a single oral dose under fasting conditions. Eight doses are planned with a starting dose of 1 mg. The ADME characteristics and absolute bioavailability using a 14C-radiolabeled microtracer will be evaluated as part of the SAD, after the first 3 cohorts have been performed. |
Drug: ACT-1004-1239
ACT-1004-1239 will be available for clinical study use as hard gelatin capsules for oral administration formulated in strengths of 1, 10, and 100 mg. For the ADME subpart, a single oral dose of 1 μCi of 14C radiolabeled ACT-1004-1239 will be given simultaneously with the ACT-1004-1239 capsule. For the absolute bioavailability subpart, a single intravenous dose of a maximum of 1 μCi of 14C radiolabeled ACT-1004-1239 will be given at the expected tmax after the administration of the ACT-1004-1239 capsule.
|
| Placebo Comparator: Placebo Matching placebo will be given as a single oral dose under fasted conditions. Matching placebo for the oral and intravenous administration of the 14C-radiolabeled ACT-1004-1239 will also be available. |
Other: Placebo
Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without ACT-1004-1239.
|
| Experimental: Food-effect subpart: ACT-1004-1239 ACT-1004-1239 will be given under both fasted (first period) and fed (second period) conditions. The food effect will be evaluated after the first 3 cohorts have been performed. |
Drug: ACT-1004-1239 (Food-effect subpart)
ACT-1004-1239 will be available for clinical study use as hard gelatin capsules for oral administration formulated in strengths of 1, 10, and 100 mg.
|
| Placebo Comparator: Food-effect subpart: Placebo Matching placebo will be given under both fasted (first period) and fed (second period) conditions. |
Other: Placebo (Food-effect subpart)
Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without ACT-1004-1239.
|
Outcome Measures
Primary Outcome Measures
- Number of patients with treatment-emergent (serious) adverse events (AEs and SAEs) [From baseline up to EOS of each cohort (total duration: up to 6 weeks)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
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Healthy male subjects aged between 18 and 55 years (inclusive) at Screening.
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No sperm donation from (first) study treatment administration up to at least 90 days after (last) study treatment administration.
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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 Criteria:
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Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
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Any previous and/or ongoing relevant immune-related disorder or any evidence for immune dysfunction based on medical history and laboratory tests at Screening
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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.
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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).
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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.
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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).
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pharmaron CPC, Inc. & Affiliates | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- Idorsia Pharmaceuticals Ltd.
Investigators
- Study Director: Clinical Trials, Idorsia Pharmaceuticals Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ID-086-101