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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: AC-083
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Changes from baseline in supine blood pressure | Supine blood pressure (mmHg) | From baseline to EOS (up to Day 12) | 
| 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) | 
| Changes from baseline in pulse rate | Pulse rate (bpm) | From baseline to EOS (up to Day 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Terminal half-life [t(1/2)] following single oral ascending doses |  | From pre-dose on Day 1 to up to Day 12 | 
| 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 |