A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Multiple Doses of Q203 in Normal Healthy Male and Female Volunteers
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|ClinicalTrials.gov Identifier: NCT02858973|
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : May 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: Q203 Drug: Placebo||Phase 1|
Six (6) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive multiple oral doses of Q203 or placebo for 14 days QD with a standard meal. Subjects will participate in only one cohort.
Safety (i.e., physical examinations, vital signs, ECGs, clinical laboratory tests, and adverse events [AEs]) will be assessed throughout the study; serial blood and urine samples will be collected for these assessments. Blood samples will also be collected for the PK assessment of Q203.
Escalation to the next dose level (i.e., initiation of the next cohort) will not take place until the Principal Investigator (PI), medical monitor, and representatives of the Sponsor have reviewed all available safety and tolerability from the previous cohorts and agree to the initiation of the next cohort.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 1B, Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Q203 When Administered Orally to Healthy Adult Subjects|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||May 8, 2018|
Placebo Comparator: Placebo
- Safety assessment through adverse event, vital signs, ECG, laboratory results, and telemetry monitoring [ Time Frame: 16 days post dose ]
- Pharmacokinetic analysis: Area under the curve [ Time Frame: 16 days post dose ]
- Pharmacokinetic analysis: Maximum observed plasma drug concentration [ Time Frame: 16 days post dose ]
- Pharmacokinetic analysis: Time of maximum observed concentration [ Time Frame: 16 days post dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858973
|United States, Nebraska|
|Lincoln, Nebraska, United States, 68502|