First-in-man Study of Single and Multiple Ascending Doses of a New Drug for Neurological Disorders

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: AC-082; Drug: Placebo

• Registration Number: NCT02702648
• Lead Sponsor: Idorsia Pharmaceuticals Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-09
• Primary Completion: 2017-03-06
• Study Completion: 2017-03-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-06
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AC-082, Single Ascending Dose	AC-082	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
Placebo, Single Ascending Dose	Placebo	Subjects receive a single dose of the matched placebo
Placebo, Multiple Ascending Dose	Placebo	Subjects receive the matched placebo for 4 days
AC-082, Multiple Ascending Dose	AC-082	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

Primary Outcome Measures

Name	Time	Method
Changes from baseline in vital signs	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	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)	Up to end of study (up to Day 11)	Treatment-emergent adverse events and treatment-emergent serious adverse events

Secondary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) following single ascending doses	From pre-dose on Day 1 to 96 hours post dose	Cmax is derived from the observed plasma concentration-time curves
Time to reach Cmax (tmax) following single ascending doses	From pre-dose on Day 1 to 96 hours post dose	tmax is derived from the observed plasma concentration-time curves
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	AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification \[AUC(0-t)\] and from zero to infinity \[AUC(0-inf)\]
Maximum plasma concentration (Cmax) 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	t(1/2) on the last day of dosing
Time to reach Cmax (tmax) 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	AUCtau is the area under the plasma concentration-time curve during a dosing interval

Trial Locations

Locations (1)

Investigator Site; 🇩🇪 Berlin, Germany