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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719197
• Other study ID #: AC-083-101
• Secondary ID: 2015-005012-15
• Status: Completed
• Phase: Phase 1
• Start date: February 19, 2016
• Est. completion date: December 1, 2016

Study information

• Verified date: July 2018
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects
• Nervous System Diseases

Intervention

Drug:
• AC-083
Hard gelatin capsules for oral administration formulated at a strengths of 1, 10 and 100 mg
• Placebo
Placebo capsules matching AC-083 capsules

Locations

Country	Name	City	State
Germany	Investigator Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)	Treatment-emergent AEs and treatment emergent serious AEs	From baseline to end of study (EOS) (up to Day 12)
Primary	Changes from baseline in supine blood pressure	Supine blood pressure (mmHg)	From baseline to EOS (up to Day 12)
Primary	Changes from baseline in electrocardiogram (ECG) variables	ECG variables are to be recorded at rest using a standard 12-lead ECG	From baseline to EOS (up to Day 12)
Primary	Changes from baseline in pulse rate	Pulse rate (bpm)	From baseline to EOS (up to Day 12)
Secondary	Maximum plasma concentration (Cmax) following single oral ascending doses	Cmax is derived from the observed plasma concentration-time curves	From pre-dose on Day 1 to up to Day 12
Secondary	Time to reach Cmax (tmax) following single oral ascending doses	Tmax is derived from the observed plasma concentration-time curves	From pre-dose on Day 1 to up to Day 12
Secondary	Terminal half-life [t(1/2)] following single oral ascending doses		From pre-dose on Day 1 to up to Day 12
Secondary	Area under the plasma concentration-time curve (AUC) following single oral ascending doses	AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification, from zero to infinity and from zero to 24 h after study drug administration	From pre-dose on Day 1 to up to Day 12