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

NCT ID: NCT02702648

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2017-03-06

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

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

AC-082

Intervention Type: DRUG

Hard gelatin capsules for oral administration

Placebo, Single Ascending Dose

Subjects receive a single dose of the matched placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched placebo capsules for oral administration

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

Group Type: EXPERIMENTAL

AC-082

Intervention Type: DRUG

Hard gelatin capsules for oral administration

Placebo, Multiple Ascending Dose

Subjects receive the matched placebo for 4 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched placebo capsules for oral administration

Interventions

AC-082

Hard gelatin capsules for oral administration

Intervention Type: DRUG

Placebo

Matched placebo capsules for oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed informed consent
• Healthy on the basis of physical examination,12-lead electrocardiogram and laboratory tests
• Males and females of non-childbearing potential, aged between 18 and 60 years (all inclusive)
• Women must have a negative serum pregnancy test at Screening and a negative urine pregnancy test predose on Day -1
• Body mass index (BMI) between 18.0 and 29.9 kg/m2 (inclusive)
• Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) between 90-140 mmHg, 50-90 mmHg and 50-90 bpm (all inclusive), respectively

Exclusion Criteria

• History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment
• Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
• Any circumstances or conditions, which, in the opinion of the Investigator, may affect full participation in the study or compliance with the protocol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karine Litherland, PhD

Role: STUDY_DIRECTOR

Actelion

Locations

Investigator Site

Berlin, , Germany

Countries

Germany

Other Identifiers

AC-082-101

Identifier Type: -

Identifier Source: org_study_id