Overview

Condition healthy subjects
Treatments ac-083, placebo
Phase phase 1
Sponsor Actelion
Start date February 2016
End date February 2017
Trial size 72 participants
Trial identifier NCT02719197, 2015-005012-15, AC-083-101

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

Recruiting in the following locations…

United States No locations recruiting
Other Countries Germany

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Arm
(Experimental)
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)
ac-083
Hard gelatin capsules for oral administration formulated at a strengths of 1, 10 and 100 mg
(Placebo Comparator)
Matched placebo administered as single ascending doses in parallel to AC-083
placebo
Placebo capsules matching AC-083 capsules

Primary Outcomes

Measure
Number of participants with adverse events (AEs)
time frame: From baseline to end of study (EOS) (up to Day 12)
Changes from baseline in supine blood pressure
time frame: From baseline to EOS (up to Day 12)
Changes from baseline in electrocardiogram (ECG) variables
time frame: From baseline to EOS (up to Day 12)
Changes from baseline in pulse rate
time frame: From baseline to EOS (up to Day 12)

Secondary Outcomes

Measure
Maximum plasma concentration (Cmax) following single oral ascending doses
time frame: From pre-dose on Day 1 to up to Day 12
Time to reach Cmax (tmax) following single oral ascending doses
time frame: From pre-dose on Day 1 to up to Day 12
Terminal half-life [t(1/2)] following single oral ascending doses
time frame: From pre-dose on Day 1 to up to Day 12
Area under the plasma concentration-time curve (AUC) following single oral ascending doses
time frame: From pre-dose on Day 1 to up to Day 12

Eligibility Criteria

Male participants from 18 years up to 45 years old.

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

Additional Information

Official title Single-center, Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Male Subjects
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Actelion.