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NCT01277692 · ClinicalTrials.gov registry record · Phase 1
A First Time in Human Study to Assess GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Patients.
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
NCT01277692 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 58 participants.
The verdict
NCT01277692, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
Study Summary
This study is a three Part, Phase 1, randomized, dose-escalation, fusion, placebo-controlled, double-blind study to determine the safety, tolerability and Pharmacokinetic (PK) profile of GSK2336805 in healthy subjects and the safety, tolerability, PK, and antiviral profile of GSK2336805 in subjects chronically infected with HCV: i. Single doses in healthy subjects and the effect of food on GSK2336805 PK (Part 1). ii. Repeat doses in healthy subjects (Part 2) iii. Single doses in chronically infected HCV positive subjects (Part 3).
Interventions
- DRUG GSK2336805 10mg
- DRUG GSK2336805 30mg
- DRUG GSK2236805 100mg
- DRUG GSK2236805 200mg
- DRUG GSK2236805 10mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2010-11-03 |
| Est. Completion | 2011-05-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01277692
The ClinicalTrials.gov registry entry for NCT01277692 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which GSK2336805 10mg is the first listed.
NCT01277692 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01277692 about?
NCT01277692 is a clinical study titled "A First Time in Human Study to Assess GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Patients.". This study is a three Part, Phase 1, randomized, dose-escalation, fusion, placebo-controlled, double-blind study to determine the safety, tolerability and Pharmacokinetic (PK) profile of GSK2336805 in healthy subjects and the safety, tolerability, PK, and antiviral profile of GSK2336805 in subjects ...
What is the current status of trial NCT01277692?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2010-11-03. Estimated completion is 2011-05-09.
What interventions are being tested in trial NCT01277692?
The interventions under investigation include: GSK2336805 10mg (DRUG), GSK2336805 30mg (DRUG), GSK2236805 100mg (DRUG), GSK2236805 200mg (DRUG), GSK2236805 10mg (DRUG).
Who is sponsoring clinical trial NCT01277692?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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