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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 is a Phase 1 study that has completed, run by Qurient Co.. The registered enrollment target is 56 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02530710
The ClinicalTrials.gov registry entry for NCT02530710 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Qurient Co., which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02530710 reports 0 study locations.
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.
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