Part A: Radiolabel Study With GW786034 Part B: Single Dose of GW786034

Phase 1

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: GW786034, oral; Drug: GW786034, radiolabeled oral; Drug: GW786034, IV

• Registration Number: NCT00478725
• Lead Sponsor: GlaxoSmithKline

Brief Summary

To study the absorption, distribution, metabolism and excretion of GW786034, and the absorption of a single IV dose of GW786034

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-24
• Study First Submitted QC: 2007-05-24
• Study First Posted: 2007-05-25
• Study Start: 2007-07-18
• Primary Completion: 2008-07-01
• Study Completion: 2008-07-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part B	GW786034, oral	characterize the pharmacokinetics of a single IV dose of GW786034
Part A	GW786034, oral	Absorption, Distribution, Metabolism and Elimination of a Single Oral \[14C\] Labeled Dose of GW786034
Part A	GW786034, radiolabeled oral	Absorption, Distribution, Metabolism and Elimination of a Single Oral \[14C\] Labeled Dose of GW786034
Part B	GW786034, IV	characterize the pharmacokinetics of a single IV dose of GW786034

Primary Outcome Measures

Name	Time	Method
Part A: excretion of radioactivity	over 168 hrs
Part B: Plasma pazopanib, clearance (CL) and AUC(0-t), AUC(0-8),Cmax and half-life (t1/2) pazopanib and pazopanib metabolites (GSK 1268992, GSK1268997, GSK1071306 and GW700201)	over 48 hrs

Secondary Outcome Measures

Name	Time	Method
Part B: Safety parameters	over 48 hrs.
Blood and plasma total radioactivity AUC(0-t), AUC(0-∞), Cmax and t1/2 following oral administration of 400 mg of [14C]-pazopanib containing approximately 70 µCi of radioactivity.	on Day 15 of Cycle 1.
Plasma pazopanib AUC(0-t), AUC(0-∞), Cmax, tmax following oral administration of 400 mg of [14C]-pazopanib containing 70 µCi of radioactivity.	on Day 15 of Cycle 1.
Blood:plasma ratio of total drug-related material (radioactivity).	on Day 15 of Cycle 1.
Plasma pazopanib AUC(0-24), Cmax, tmax following oral administration of 800 mg pazopanib	on Day 15 of Cycle 1.
Safety parameters: adverse events (AEs), vital signs, electrocardiograms (ECGs) and clinical laboratory assessments.	on Day 15 of Cycle 1.
Part A: Blood and plasma total radioactivity AUC(0-t), AUC(0-8),Cmax and t1/2	over 168 hrs.
Samples (for use in a separate study) to characterize and quantify metabolites of pazopanib in plasma, urine and feces.	on Day 15 of Cycle 1.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Nashville, Tennessee, United States