A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: atorvastatin; Drug: dalcetrapib

• Registration Number: NCT01363999
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-31
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2019-07-17
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-13
• Last Update Submitted: 2019-12-13
• Results First Posted: 2019-12-17
• Last Update Posted: 2019-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy volunteers, 18 to 55 years of age, inclusive

Exclusion Criteria

• Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the patient
• Clinically significant abnormal laboratory values

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
D	dalcetrapib	RO4607381/F49 tablet
A	dalcetrapib	RO5317116/F01 bilayer tablet
A	atorvastatin	RO5317116/F01 bilayer tablet
B	dalcetrapib	RO5317116/F03 bilayer tablet
B	atorvastatin	RO5317116/F03 bilayer tablet
C	atorvastatin	RO5317116/F04 active-coated tablet
C	dalcetrapib	RO5317116/F04 active-coated tablet
D	atorvastatin	RO4607381/F49 tablet

Primary Outcome Measures

Name	Time	Method
Plasma Concentration of Dalcetrapib Active Form	3 days
Plasma Concentration of Atorvastatin	3 days

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of Serious Adverse Events	9 weeks
Plasma Concentration of Atorvastatin Metabolites	3 days	Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma.