First-in-man Study of Single Ascending Dose of a New Drug for Neurological Disorders

NCT ID: NCT02719197

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-19
• Study Completion Date: 2016-12-01

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 male adults

Conditions

Healthy Subjects

Study Design

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

Study Groups

AC-083, Single Ascending Dose

AC-083 administered at different single dose levels in a sequential manner, and in a maximum of 9 dose levels starting from 1 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort). Each dose level will be investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo)

Group Type: EXPERIMENTAL

AC-083

Intervention Type: DRUG

Hard gelatin capsules for oral administration formulated at a strengths of 1, 10 and 100 mg

Placebo, Single Ascending Dose

Matched placebo administered as single ascending doses in parallel to AC-083

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsules matching AC-083 capsules

Interventions

AC-083

Hard gelatin capsules for oral administration formulated at a strengths of 1, 10 and 100 mg

Intervention Type: DRUG

Placebo

Placebo capsules matching AC-083 capsules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed informed consent
• Healthy on the basis of physical examination, electrocardiogram and laboratory tests.
• A subject who has a female partner of childbearing potential or a pregnant partner agrees to use a condom in combination with spermicide or a condom, respectively, from screening, during the entire study, and for at least 3 months after (the last) study drug intake
• Body mass index (BMI) of 18.0 to 29.9 kg/m2 (inclusive) at screening and Day -1.
• Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured after 5 min in the supine position at screening and at Day -1.

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 cardiac condition or illness with a potential to increase the cardiac risk of the subject based on medical history, physical examination, or electrocardiogram (ECG) evaluations
• 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: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigator Site

Berlin, , Germany

Countries

Germany

Other Identifiers

2015-005012-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AC-083-101

Identifier Type: -

Identifier Source: org_study_id