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NCT02530710 · ClinicalTrials.gov registry record · Phase 1
A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single Doses of Q203 in Normal, Healthy, Male and Female Volunteers
A Phase 1 study, sponsored by Qurient Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT02530710: Completed Phase 1 study, sponsored by Qurient Co..
NCT02530710 is a Phase 1 study that has completed, run by Qurient Co.. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02530710, a Phase 1 study, has completed, sponsored by Qurient Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and female volunteers. Subjects will be randomly assigned to 1 of 7 treatment cohorts (Cohorts 1 - 7) of 8 subjects each, to receive either Q203 or placebo (6 active treatment : 2 placebo) in a fasting state. Dose escalation to the next cohort may be considered when at least 6 out of 8 subjects, in a cohort, completes all procedures and none of the subjects has a clinically significant adverse event (AE) that is being followed, or at the discretion of the PI if no drug-related serious adverse events (SAEs) have occurred. A food effect cohort will be enrolled to test administration of Q203 in a fed state, at 100 mg dose level (this dose level may change based on PK analysis results). Subjects who received 100mg dose in a fasting state will return and receive the second dose, with food. Subjects will be followed up for AEs, SAE or pregnancy for 30 days postdrug administration.
Interventions
- DRUG Placebo
- DRUG Q203
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2015-08 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
What the finished NCT02530710 record still lists
NCT02530710 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02530710 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02530710 about?
NCT02530710 is a clinical study titled "A Dose-Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of Single Doses of Q203 in Normal, Healthy, Male and Female Volunteers". Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and female volunteers. Subjects will be randomly assigned to 1 of 7 treatment cohorts (Cohorts 1 - 7) of 8 subjects each, to receive either Q203 or placebo (6 active treatment : 2 placebo) in a fasting state. Dose e...
What is the current status of trial NCT02530710?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2015-08. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02530710?
The interventions under investigation include: Placebo (DRUG), Q203 (DRUG).
Who is sponsoring clinical trial NCT02530710?
This trial is sponsored by Qurient Co., which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02530710's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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