NCT04608513
Completed
Phase 1
A Single-center, Double-blind, Randomized, 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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy
- Sponsor
- Idorsia Pharmaceuticals Ltd.
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Safety profile including incidence of treatment-emergent adverse events.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •General criteria
- •Signed informed consent prior to any study-mandated procedure.
- •Healthy male subjects (both study parts) and female subjects of nonchildbearing potential (Part B) aged between 18 and 55 years (inclusive) at Screening.
- •Healthy on the basis of medical history, physical examination, cardiovascular assessments, and clinical laboratory tests.
- •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
- •Previous exposure to the study medication.
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- •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.
- •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.
- •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).
Arms & Interventions
Placebo single dose (dose level 2)
Soft capsule for oral administration
Intervention: Placebo
Placebo multiple dose (dose level 4)
Soft capsule for oral administration
Intervention: Placebo
ACT-1014-6470 single dose (dose level 2)
Soft capsule for oral administration
Intervention: ACT-1014-6470
ACT-1014-6470 single dose (dose level 1)
Soft capsule for oral administration
Intervention: ACT-1014-6470
Placebo single dose (dose level 1)
Soft capsule for oral administration
Intervention: Placebo
ACT-1014-6470 multiple dose (dose level 1)
Soft capsule for oral administration
Intervention: ACT-1014-6470
Placebo multiple dose (dose level 1)
Soft capsule for oral administration
Intervention: Placebo
ACT-1014-6470 multiple dose (dose level 2)
Soft capsule for oral administration
Intervention: ACT-1014-6470
Placebo multiple dose (dose level 2)
Soft capsule for oral administration
Intervention: Placebo
ACT-1014-6470 multiple dose (dose level 3)
Soft capsule for oral administration
Intervention: ACT-1014-6470
Placebo multiple dose (dose level 3)
Soft capsule for oral administration
Intervention: Placebo
ACT-1014-6470 multiple dose (dose level 4)
Soft capsule for oral administration
Intervention: ACT-1014-6470
Outcomes
Primary Outcomes
Safety profile including incidence of treatment-emergent adverse events.
Time Frame: 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 Outcomes
- 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 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 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 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): 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): 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).)
- 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).)
Study Sites (1)
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