Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00605761 · ClinicalTrials.gov registry record · Phase 1
SD Cystic Fibrosis Study
A Phase 1 study of Cystic Fibrosis, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 3
- Study locations
NCT00605761 is a Phase 1 study of Cystic Fibrosis that has completed, run by GlaxoSmithKline. The registered enrollment target is 9 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (95% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT00605761, a Phase 1 study of Cystic Fibrosis, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 3
- Study locations
Study Summary
Subject with Cystic Fibrosis have increased clearance of many drugs. Based on pre-clinical data SB656933 was found to have low clearance and high bio-availability. This study will characterize the PK profile of a single dose of SB656933 in patients with Cystic Fibrosis. There will be two groups of subjects. The first group of subjects will receive a single dose of 50mg SB-656933. The second group of subjects will receive a single dose of up to 300 mg SB-656933. Subjects will first be screened for eligibility related to cystic fibrosis history. Safety evaluations will be undertaken and plasma samples for pharmacokinetic analysis will be collected. Additional blood samples will be taken for the pharmacodynamic endpoints CD11b and GAFS. Subjects are not required to stay overnight after their 12 hour PK sample collection on Day 1, although they may do so if they wish. On Day 2 and 3, they will return for collection of additional safety measurements, and further plasma and blood samples will be taken for 24 and 48 h pharmacokinetics and 24h CD11b/GAFS measurements, respectively. A follow up visit (Visit 3) will be made 4-7 days after the treatment period. Subjects will be enrolled in the study for approximately 3to 7 weeks (from screening to follow-up).
Conditions Studied
Interventions
- DRUG SB656933
Study Locations (3)
California
- GSK Investigational Site - Palo Alto
Minnesota
- GSK Investigational Site - Minneapolis
Pennsylvania
- GSK Investigational Site - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2008-02 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00605761
The ClinicalTrials.gov registry entry for NCT00605761 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (95% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which SB656933 is the first listed.
NCT00605761 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Minnesota, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00605761 about?
NCT00605761 is a clinical study titled "SD Cystic Fibrosis Study". Subject with Cystic Fibrosis have increased clearance of many drugs. Based on pre-clinical data SB656933 was found to have low clearance and high bio-availability. This study will characterize the PK profile of a single dose of SB656933 in patients with Cystic Fibrosis. There will be two groups of s...
What is the current status of trial NCT00605761?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2008-02. Estimated completion is 2008-12.
What conditions does trial NCT00605761 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT00605761?
The interventions under investigation include: SB656933 (DRUG).
Who is sponsoring clinical trial NCT00605761?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00605761 being conducted?
This trial has 3 study locations across California, Minnesota, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
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.
-
Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease
RECRUITING · Phase 1
-
A Study Assessing KB407 for the Treatment of Cystic Fibrosis
RECRUITING · Phase 1
-
Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants
RECRUITING · Phase 1
-
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)
RECRUITING · Phase 1
-
Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis
RECRUITING · Phase 1
-
A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.