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
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 adults
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 |
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 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 |
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