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

Healthy Subjects Clinical Trial

Official title:

Single-center, Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Effect), and Pharmacodynamics of an Oral Drug for Neurological Disorders in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702648
• Other study ID #: AC-082-101
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2016
• Est. completion date: March 6, 2017

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 adults

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 6, 2017
• Est. primary completion date: March 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects
• Nervous System Diseases

Intervention

Drug:
• AC-082
Hard gelatin capsules for oral administration
• Placebo
Matched placebo capsules for oral administration

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 adverse events and treatment-emergent serious adverse events	Up to end of study (up to Day 11)
Primary	Changes from baseline in vital signs	Vital signs include diastolic and systolic blood pressure and pulse rate	Up to end of study (up to Day 11)
Primary	Changes from baseline in ECG variables	ECG variables are to be recorded at rest using a standard 12-lead ECG	Up to end of study (up to day 11)
Secondary	Maximum plasma concentration (Cmax) following single ascending doses	Cmax is derived from the observed plasma concentration-time curves	From pre-dose on Day 1 to 96 hours post dose
Secondary	Time to reach Cmax (tmax) following single ascending doses	tmax is derived from the observed plasma concentration-time curves	From pre-dose on Day 1 to 96 hours post dose
Secondary	Terminal half-life [t(1/2)] following single ascending doses		From pre-dose on Day 1 to 96 hours post dose
Secondary	Area under the plasma concentration-time curve (AUC) following single ascending doses	AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification [AUC(0-t)] and from zero to infinity [AUC(0-inf)]	From pre-dose on Day 1 to 96 hours post dose
Secondary	Maximum plasma concentration (Cmax) following multiple ascending doses		Up to 96 hours following the last dose administration on Day 4
Secondary	Time to reach Cmax (tmax) following multiple ascending doses		Up to 96 hours following the last dose administration on Day 4
Secondary	Terminal half-life [t(1/2)] following multiple ascending doses	t(1/2) on the last day of dosing	Up to 96 hours following the last dose administration on Day 4
Secondary	Area under the plasma concentration-time curve during a dosing interval (AUCtau)	AUCtau is the area under the plasma concentration-time curve during a dosing interval	Day 1 and Day 4