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NCT01585636 · ClinicalTrials.gov registry record · Phase 1
Escalating Single-dose Safety, Tolerability, and Pharmacokinetics of SQ109 in Healthy Volunteers
A Phase 1 study of Tuberculosis, sponsored by Sequella.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT01585636: Completed Phase 1 study of Tuberculosis, sponsored by Sequella.
NCT01585636 is a Phase 1 study of Tuberculosis that has completed, run by Sequella. The registered enrollment target is 62 participants, below the 932-participant average among 29 other Tuberculosis trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01585636, a Phase 1 study of Tuberculosis, has completed, sponsored by Sequella.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase 1, "first in man" study to evaluate single oral doses (5-300 mg) of SQ109, a new investigational drug being developed for treatment of tuberculosis. If single doses are safe and well tolerated, subsequent studies will evaluate multiple daily doses in healthy volunteers and patients with pulmonary tuberculosis.
Primary Outcome
Compared to baseline measurements: Change in Hb, Hct, WBC count / differential, platelet count Change in serum chemistry parameters Change in visual acuity Alteration in color perception Changes in cranial, sensory or motor nerve function, and mental status (as defined by the mini mental status examination) Prolongation in QTc interval, and rhythm changes by electrocardiogram
Conditions Studied
Interventions
- DRUG SQ109
Study Locations (1)
Kansas
- Quintiles Phaes 1 Clinical Study Unit - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2006-09 |
| Est. Completion | 2007-02 |
| Phase | Phase 1 |
What the finished NCT01585636 record still lists
NCT01585636 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 932-participant average among 29 other Tuberculosis trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Tuberculosis appearing as the primary indexed condition, and to 1 intervention - of which SQ109 is the first listed.
NCT01585636 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT01585636 about?
NCT01585636 is a clinical study titled "Escalating Single-dose Safety, Tolerability, and Pharmacokinetics of SQ109 in Healthy Volunteers". This is a phase 1, "first in man" study to evaluate single oral doses (5-300 mg) of SQ109, a new investigational drug being developed for treatment of tuberculosis. If single doses are safe and well tolerated, subsequent studies will evaluate multiple daily doses in healthy volunteers and patients w...
What is the current status of trial NCT01585636?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2006-09. Estimated completion is 2007-02.
What conditions does trial NCT01585636 study?
This clinical trial studies the following conditions: Tuberculosis.
What interventions are being tested in trial NCT01585636?
The interventions under investigation include: SQ109 (DRUG).
Who is sponsoring clinical trial NCT01585636?
This trial is sponsored by Sequella, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01585636 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tuberculosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01585636's enrollment target sits among peer trials
62 21st of 29 higher than 9 of 29 other Tuberculosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tuberculosis 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.
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