A Phase 1 interventional study of SB656933 and SB656933 in Cystic Fibrosis, sponsored by GlaxoSmithKline. Completed at 3 sites in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2012-03-19.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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).
1,605 studies on the registry are indexed under Cystic Fibrosis; 196 are open to participants now.
This study's enrollment of 9 is below the median of 36 across 1,051 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
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Exclusion Criteria:
50 mg treatment
Drug: SB656933
150 mg treatment
Drug: SB656933
Blood samples
Time frame: over a 48 hour time-period after single dosing with either 50mg or up tp 300mg SB656933
Safety: ECG, vital signs, clinical labs
Time frame: over 48hours post SB656933 dosing in both dosing sessions
Continuous adverse event monitoring
Time frame: from dosing until study conclusion and follow up, 4-7 days after the treatment period
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SB 656933