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

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo; Drug: AC-082

Study type: Interventional

Funder types: Industry

Identifiers

NCT02702648

AC-082-101

Details and patient eligibility

About

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

Enrollment: 128 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 4 patient groups, including a placebo group

AC-082, Single Ascending Dose

Experimental group

Description:

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

Treatment:

Drug: AC-082

Placebo, Single Ascending Dose

Placebo Comparator group

Description:

Subjects receive a single dose of the matched placebo

Treatment:

Drug: Placebo

AC-082, Multiple Ascending Dose

Experimental group

Description:

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

Treatment:

Drug: AC-082

Placebo, Multiple Ascending Dose

Placebo Comparator group

Description:

Subjects receive the matched placebo for 4 days

Treatment:

Drug: Placebo