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
Verified date | July 2018 |
Source | Idorsia Pharmaceuticals Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Investigator Site | Berlin |
Lead Sponsor | Collaborator |
---|---|
Idorsia Pharmaceuticals Ltd. |
Germany,
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 |
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