A Placebo-controlled Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects
Study Details
Study Description
Brief Summary
A safety and tolerability study in healthy subjects including examination of how the body takes up, distributes, and gets rid of ACT-1014-6470
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: ACT-1014-6470 single dose (dose level 1) Soft capsule for oral administration |
Drug: ACT-1014-6470
Soft capsules for oral administration
|
Placebo Comparator: Placebo single dose (dose level 1) Soft capsule for oral administration |
Drug: Placebo
Soft capsules for oral administration
|
Experimental: ACT-1014-6470 single dose (dose level 2) Soft capsule for oral administration |
Drug: ACT-1014-6470
Soft capsules for oral administration
|
Placebo Comparator: Placebo single dose (dose level 2) Soft capsule for oral administration |
Drug: Placebo
Soft capsules for oral administration
|
Experimental: ACT-1014-6470 multiple dose (dose level 1) Soft capsule for oral administration |
Drug: ACT-1014-6470
Soft capsules for oral administration
|
Placebo Comparator: Placebo multiple dose (dose level 1) Soft capsule for oral administration |
Drug: Placebo
Soft capsules for oral administration
|
Experimental: ACT-1014-6470 multiple dose (dose level 2) Soft capsule for oral administration |
Drug: ACT-1014-6470
Soft capsules for oral administration
|
Placebo Comparator: Placebo multiple dose (dose level 2) Soft capsule for oral administration |
Drug: Placebo
Soft capsules for oral administration
|
Experimental: ACT-1014-6470 multiple dose (dose level 3) Soft capsule for oral administration |
Drug: ACT-1014-6470
Soft capsules for oral administration
|
Placebo Comparator: Placebo multiple dose (dose level 3) Soft capsule for oral administration |
Drug: Placebo
Soft capsules for oral administration
|
Experimental: ACT-1014-6470 multiple dose (dose level 4) Soft capsule for oral administration |
Drug: ACT-1014-6470
Soft capsules for oral administration
|
Placebo Comparator: Placebo multiple dose (dose level 4) Soft capsule for oral administration |
Drug: Placebo
Soft capsules for oral administration
|
Outcome Measures
Primary Outcome Measures
- Safety profile including incidence of treatment-emergent adverse events. [Safety and tolerability assessments will be performed at predefined time points from Day 1 to Day 4 in Part A and Day 1 to Day 10 in Part B (total duration: max. 50 days).]
Secondary Outcome Measures
- Part A - Single ascending dose (SAD): Area under the plasma concentration-time curve (AUC) from zero to time t of the last measured concentration above the limit of quantification (AUC0-t). [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).]
- Part A - Single ascending dose (SAD): Area under the plasma concentration-time curve (AUC) from zero to infinity (AUC0-inf). [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).]
- Part A - Single ascending dose (SAD): Maximum plasma concentration (Cmax). [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).]
- Part A - Single ascending dose (SAD): Time to reach Cmax (tmax). [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).]
- Part A - Single ascending dose (SAD): Terminal half-life (t½). [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 4 (total duration: max. 4 days).]
- Part B - Multiple ascending dose (MAD): AUC during a dosing interval (AUCτ) following the first and the last dose. [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 10 (total duration: max. 10 days).]
- Part B - Multiple ascending dose (MAD): Cmax of the first and the last dosing interval. [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 10 (total duration: max. 10 days).]
- Part B - Multiple ascending dose (MAD): tmax of the first and the last dosing interval. [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 10 (total duration: max. 10 days).]
- Part B - Multiple ascending dose (MAD): t½ after last dose administration. [Blood samples for the determination of the PK parameters will be collected at predefined time points from Day 1 to Day 10 (total duration: max. 10 days).]
Eligibility Criteria
Criteria
Inclusion Criteria:
General criteria
-
Signed informed consent prior to any study-mandated procedure.
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Healthy male subjects (both study parts) and female subjects of nonchildbearing potential (Part B) aged between 18 and 55 years (inclusive) at Screening.
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Healthy on the basis of medical history, physical examination, cardiovascular assessments, and clinical laboratory tests.
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Male subjects with a partner that might become pregnant must either be vasectomized or agree to practice adequate contraception from admission to the study site until 3 months after dosing, or the partner must consistently and correctly use (from Screening, during the entire study, and for at least 3 months after last study treatment intake) a highly effective method of contraception.
Criteria for Part B only:
• Women of non-childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day-1.
Exclusion Criteria:
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Previous exposure to the study medication.
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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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History or clinical evidence of any disease and/or existence of any surgical or medical condition, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment.
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Relevant bacterial, viral, fungal, or protozoal infection that manifested within the last 6 weeks prior to Screening and/or ongoing relevant bacterial, viral, fungal, or protozoal infection, as judged by the investigator, and/or evidence of immune dysfunction based on laboratory tests at Screening.
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Any signs or symptoms of active, ongoing infection judged to be clinically relevant by the investigator (special attention should be given to clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, sore throat, or fatigue).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Parexel International GmbH Klinikum Westend | Berlin | Germany | 14050 |
Sponsors and Collaborators
- Idorsia Pharmaceuticals Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ID-087-102