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NCT01523990 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, and PK in Healthy Volunteers and HCV Genotype 1 Infected Patients
A Phase 1 study, sponsored by TaiGen Biotechnology Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 135
- Enrollment target
NCT01523990: Completed Phase 1 study, sponsored by TaiGen Biotechnology Co..
NCT01523990 is a Phase 1 study that has completed, run by TaiGen Biotechnology Co.. The registered enrollment target is 135 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01523990, a Phase 1 study, has completed, sponsored by TaiGen Biotechnology Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 135 participants
- Enrollment target
Study Summary
A Safety Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in HCV Genotype 1 Infected Patients
Primary Outcome
Dose proportionality will be assessed by evaluating PK parameters AUC0-t, AUC0-inf, and Cmax. Parameters that are not dose dependent will be assessed by evaluating Tmax, t1/2, and λz. The linear relationship between the log-transformed PK parameter and the natural log of the dose will be tested using a linear lack-of-fit test. The dose-dependent parameters will not be dose normalized. Residual analysis will be used to assess the assumptions of normality and variance homogeneity for the statistic
Interventions
- DRUG placebo
- DRUG TG-2349
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
What the finished NCT01523990 record still lists
NCT01523990 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (125% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01523990 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01523990 about?
NCT01523990 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and PK in Healthy Volunteers and HCV Genotype 1 Infected Patients". A Safety Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in HCV Genotype 1 Infected Patients
What is the current status of trial NCT01523990?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 135 participants. The study started on 2011-10. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01523990?
The interventions under investigation include: placebo (DRUG), TG-2349 (DRUG).
Who is sponsoring clinical trial NCT01523990?
This trial is sponsored by TaiGen Biotechnology Co., which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01523990's enrollment target sits among peer trials
135 425th of 2000 higher than 1,574 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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