NCT01751074

To Estimate the Potential Effects of Repeat Doses of Darapladib on the Pharmacokinetics (PK) of Rosuvastatin as Well as Evaluating Safety and Tolerability in Healthy Volunteers

Completed Phase 1 Last updated 26 July 2017

What this trial tests

Phase 1 trial testing Rosuvastatin 10 mg in Atherosclerosis in 18 participants. Completed in 14 March 2013.

Timeline

17 December 2012

Primary endpoint
14 March 2013

14 March 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	17 December 2012
Primary completion	14 March 2013
Estimated completion	14 March 2013
Sites	1 location across United States

Drugs / interventions tested

• Rosuvastatin 10 mg
• Darapladib 160 mg — full drug profile →

Conditions studied

• Atherosclerosis — all drugs for Atherosclerosis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 20 to 64, any sex, with Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The potential for a drug interaction between Darapladib and Rosuvastatin is felt to be low and it would be helpful to quantify this risk in man in order to guide prescribing physicians. The primary aims of this study are to estimate the potential effects of repeat doses of Darapladib on the PK of Rosuvastatin as well as evaluating safety and tolerability. Two part approaches are planned for this study. Part A of the study will examine the effects of repeat doses Darapladib on the PK of Rosuvastatin in healthy volunteers of Caucasian descent. Based on whether a significant increase in Rosuvastatin exposure is observed in Caucasians in Part A, a decision will be made regarding whether to proceed with a conditional Part B to examine this effect in healthy volunteers of Far-East Asian descent.

In both parts, subjects will receive Rosuvastatin 10 milligrams (mg) once daily (QD) for 1 day during the first treatment period (Treatment Period 1), followed by a 4 day PK sampling period/wash-out. Subjects will then receive darapladib 160 mg QD for the next 10 days with 24-hour PK sampling on the last day (Day 14 of the study). Immediately following this, all subjects will then receive the combination of Darapladib 160 mg and Rosuvastatin 10 mg for 1 day and continued Darapladib dosing of 160 mg QD for additional 3 days (Treatment Period 2) while blood samples are collected to assess Rosuvastatin PK. Plasma samples collected on Day 15 will be analyzed for both Rosuvastatin and Darapladib concentrations.

Subjects will be required to return to the unit approximately 10 to 14 days following the last dose of study medication for a clinic visit for assessments and then will return again at 35 ±7 days following the last dose for the final follow-up visit of the study. The duration of each subject's participation in the study from screening to follow-up will be approximately three months.

Approximately 18 evaluable subjects will be enrolled in Part A and another 18 subjects will be enrolled in Part B (if conducted) to complete dosing and all assessments.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.