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

• Sponsor: Idorsia Pharmaceuticals Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02719197
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.4
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: AC-083; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Feb 19, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AC-083, Single Ascending Dose 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)	Drug: AC-083; Hard gelatin capsules for oral administration formulated at a strengths of 1, 10 and 100 mg
Placebo Comparator: Placebo, Single Ascending Dose Matched placebo administered as single ascending doses in parallel to AC-083	Drug: Placebo; Placebo capsules matching AC-083 capsules

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events (AEs) [From baseline to end of study (EOS) (up to Day 12)]

   Treatment-emergent AEs and treatment emergent serious AEs

2. Changes from baseline in supine blood pressure [From baseline to EOS (up to Day 12)]

   Supine blood pressure (mmHg)

3. Changes from baseline in electrocardiogram (ECG) variables [From baseline to EOS (up to Day 12)]

   ECG variables are to be recorded at rest using a standard 12-lead ECG

4. Changes from baseline in pulse rate [From baseline to EOS (up to Day 12)]

   Pulse rate (bpm)

Secondary Outcome Measures

1. Maximum plasma concentration (Cmax) following single oral ascending doses [From pre-dose on Day 1 to up to Day 12]

   Cmax is derived from the observed plasma concentration-time curves

2. Time to reach Cmax (tmax) following single oral ascending doses [From pre-dose on Day 1 to up to Day 12]

   Tmax is derived from the observed plasma concentration-time curves

3. Terminal half-life [t(1/2)] following single oral ascending doses [From pre-dose on Day 1 to up to Day 12]

4. Area under the plasma concentration-time curve (AUC) following single oral ascending doses [From pre-dose on Day 1 to up to Day 12]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigator Site	Berlin		Germany	14050

Sponsors and Collaborators

• Idorsia Pharmaceuticals Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Idorsia Pharmaceuticals Ltd.
• ClinicalTrials.gov Identifier: NCT02719197
• Other Study ID Numbers: AC-083-101; 2015-005012-15
• First Posted: Mar 25, 2016
• Last Update Posted: Jul 10, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Nervous System Diseases

Study Results

No Results Posted as of Jul 10, 2018