Study to Evaluate Systemic Bioavailability of Oral OTS167 in Healthy Adult Subjects
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|ClinicalTrials.gov Identifier: NCT02768519|
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : June 1, 2017
The purpose of this study is to determine the indicative bioavailability of a single oral dose of OTS167, and to evaluate the effects of food on OTS167 pharmacokinetics (PK) after oral dosing.
Eleven male and female healthy participants aged 45 years and over will be entered into this phase 1, single-centre, double-blind, randomised, cross-over study. The trial is designed to evaluate the bioavailability of OTS167, and the effects of food on pharmacokinetics (PK) of OTS167 when administered by the oral route. Correlative studies include evaluation of safety endpoints and examinations, and adverse events. This study involves 3 cohorts to evaluate the safety and tolerability of oral dosing from lower dose.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: OTS167IV Other: Cherry syrup||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1, Randomised, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Systemic Bioavailability of Oral OTS167 Under Fed and Fasting Conditions in Healthy Adult Subjects|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Cohort 1: 0.5 mg, Cohort 2: 1.0 mg, and Cohort 3: 2.0 mg without food on Period 1 Day 1 and with food on Day 1 Period 2.
diluted to final concentration with cherry syrup
Placebo Comparator: Placebo
Other: Cherry syrup
- Safety: Participants to be monitored throughout the treatment and follow-up period for occurrence of adverse events (AEs) (acute, delayed, and/or cumulative), as well as for changes in clinical status, vital signs, and laboratory data. [ Time Frame: 7 days after final study drug administration. ]Safety assessments include concomitant medication survey, adverse events, temperature, pulse and respiratory rate, blood pressure, physical examination, hematologic parameters, serum chemistries, coagulation parameters, urinalyses, and 12-Lead ECG and cardiac telemetry.
- Maximum Plasma Concentration (Cmax) [ Time Frame: 24 hours after final study drug administration. ]
- Time of Maximum concentration (Tmax) [ Time Frame: 24 hours after final study drug administration. ]
- Area Under the Curve (AUC) [ Time Frame: 24 hours after final study drug administration. ]
- Half life (T1/2) [ Time Frame: 24 hours after final study drug administration. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768519
|Australia, South Australia|
|CMAX, Royal Adelaide Hospital|
|Adelaide, South Australia, Australia, 5000|
|Principal Investigator:||Sepehr Shakib||CMAX (A division of IDT Australia Ltd)|