First-in-man Study of Single Ascending Dose of a New Drug for Neurological Disorders
- Registration Number
- NCT02719197
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 72
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AC-083, Single Ascending Dose AC-083 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) Placebo, Single Ascending Dose Placebo Matched placebo administered as single ascending doses in parallel to AC-083
- Primary Outcome Measures
Name Time Method 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
Changes from baseline in supine blood pressure From baseline to EOS (up to Day 12) Supine blood pressure (mmHg)
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
Changes from baseline in pulse rate From baseline to EOS (up to Day 12) Pulse rate (bpm)
- Secondary Outcome Measures
Name Time Method 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
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
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 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
Trial Locations
- Locations (1)
Investigator Site
🇩🇪Berlin, Germany