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NCT02033668 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic (PK) Study of GSK933776 in Healthy Volunteers
A Phase 1 study of Atrophy, Geographic, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT02033668: Completed Phase 1 study of Atrophy, Geographic, sponsored by GlaxoSmithKline.
NCT02033668 is a Phase 1 study of Atrophy, Geographic that has completed, run by GlaxoSmithKline. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02033668, a Phase 1 study of Atrophy, Geographic, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is intended to enable a possible transition to intramuscular (IM) or subcutaneous (SQ) administration for subsequent studies with GSK933776 by characterizing the safety, tolerability, PK and pharmacodynamic profiles, and immunogenicity of GSK933776 following IM and SQ administration in healthy volunteers. Such alternate routes of administration may provide more options in the selection of an efficacious dose for subsequent development in patients with geographic atrophy. There will be four treatment arms in the study and participants will be assigned to 1 of 4 possible treatment arms in a 1:1:1:1 ratio. The planned number of evaluable participants for this study is 24 with 6 participants completing all critical assessments in each of the four treatment arms. The total duration of participation from screening to follow-up for Treatment Arms A, B and D (single dose of GSK933776), will be approximately 113 days and total duration for Treatment Arm C (repeat dose of GSK933776) will be approximately 134 days.
Primary Outcome
Bioavailability is defined as the rate and extent to which drug reaches the systemic circulation. The relative bioavailability will be calculated from the ratio of area under concentration time curve from time zero to infinity (AUC \[0-infinity\]) following single dose SQ and IM injection to intravenous (IV) infusion
Conditions Studied
Interventions
- DRUG GSK933776 for SQ administration
- DRUG GSK933776 for IM administration
- DRUG GSK933776 for IV administration
Study Locations (1)
Kansas
- GSK Investigational Site - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-01-22 |
| Est. Completion | 2014-07-15 |
| Phase | Phase 1 |
What the finished NCT02033668 record still lists
NCT02033668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Atrophy, Geographic appearing as the primary indexed condition, and to 3 interventions - of which GSK933776 for SQ administration is the first listed.
NCT02033668 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT02033668 about?
NCT02033668 is a clinical study titled "Pharmacokinetic (PK) Study of GSK933776 in Healthy Volunteers". This study is intended to enable a possible transition to intramuscular (IM) or subcutaneous (SQ) administration for subsequent studies with GSK933776 by characterizing the safety, tolerability, PK and pharmacodynamic profiles, and immunogenicity of GSK933776 following IM and SQ administration in he...
What is the current status of trial NCT02033668?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2014-01-22. Estimated completion is 2014-07-15.
What conditions does trial NCT02033668 study?
This clinical trial studies the following conditions: Atrophy, Geographic.
What interventions are being tested in trial NCT02033668?
The interventions under investigation include: GSK933776 for SQ administration (DRUG), GSK933776 for IM administration (DRUG), GSK933776 for IV administration (DRUG).
Who is sponsoring clinical trial NCT02033668?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02033668 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
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Where NCT02033668's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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