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

NCT02719197 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-07-10

No results posted yet for this study

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

Interventions

DRUG

AC-083

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

DRUG

Placebo

Placebo capsules matching AC-083 capsules

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-19
Primary Completion
2016-12-01
Completion
2016-12-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02719197 on ClinicalTrials.gov