Single-center, Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- AC-082
- Conditions
- Healthy Subjects
- Sponsor
- Idorsia Pharmaceuticals Ltd.
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Changes from baseline in vital signs
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy adults
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
AC-082, Single Ascending Dose
Subjects receive AC-082 at different single dose levels in a sequential manner, starting from 10 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each subject can participate in only one dose level
Intervention: AC-082
Placebo, Single Ascending Dose
Subjects receive a single dose of the matched placebo
Intervention: Placebo
AC-082, Multiple Ascending Dose
Subjects receive AC-082 at different dose levels for 4 consecutive days in a sequential manner (dose levels and duration to be adapted according to the results of the single ascending dose cohorts). Each subject can participate in only one dose level
Intervention: AC-082
Placebo, Multiple Ascending Dose
Subjects receive the matched placebo for 4 days
Intervention: Placebo
Outcomes
Primary Outcomes
Changes from baseline in vital signs
Time Frame: Up to end of study (up to Day 11)
Vital signs include diastolic and systolic blood pressure and pulse rate
Changes from baseline in ECG variables
Time Frame: Up to end of study (up to day 11)
ECG variables are to be recorded at rest using a standard 12-lead ECG
Number of participants with adverse events (AEs)
Time Frame: Up to end of study (up to Day 11)
Treatment-emergent adverse events and treatment-emergent serious adverse events
Secondary Outcomes
- Maximum plasma concentration (Cmax) following single ascending doses(From pre-dose on Day 1 to 96 hours post dose)
- Time to reach Cmax (tmax) following single ascending doses(From pre-dose on Day 1 to 96 hours post dose)
- Terminal half-life [t(1/2)] following single ascending doses(From pre-dose on Day 1 to 96 hours post dose)
- Area under the plasma concentration-time curve (AUC) following single ascending doses(From pre-dose on Day 1 to 96 hours post dose)
- Maximum plasma concentration (Cmax) following multiple ascending doses(Up to 96 hours following the last dose administration on Day 4)
- Time to reach Cmax (tmax) following multiple ascending doses(Up to 96 hours following the last dose administration on Day 4)
- Terminal half-life [t(1/2)] following multiple ascending doses(Up to 96 hours following the last dose administration on Day 4)
- Area under the plasma concentration-time curve during a dosing interval (AUCtau)(Day 1 and Day 4)