Healthy Clinical Trial
Official title:
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
Verified date | October 2021 |
Source | Idorsia Pharmaceuticals Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A safety and tolerability study in healthy subjects including examination of how the body takes up, distributes, and gets rid of ACT-1014-6470
Status | Completed |
Enrollment | 46 |
Est. completion date | September 20, 2021 |
Est. primary completion date | September 20, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Germany | Parexel International GmbH Klinikum Westend | Berlin |
Lead Sponsor | Collaborator |
---|---|
Idorsia Pharmaceuticals Ltd. |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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). | ||
Secondary | 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). | ||
Secondary | 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). | ||
Secondary | 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). | ||
Secondary | 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). | ||
Secondary | Part B - Multiple ascending dose (MAD): AUC during a dosing interval (AUCt) 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). | ||
Secondary | 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). | ||
Secondary | 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). | ||
Secondary | 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). |
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