A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: atorvastatin; Drug: dalcetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01363999

WP25642

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

A

Experimental group

Description:

RO5317116/F01 bilayer tablet

Treatment:

Drug: dalcetrapib

Drug: atorvastatin

B

Experimental group

Description:

RO5317116/F03 bilayer tablet

Treatment:

Drug: dalcetrapib

Drug: atorvastatin

C

Experimental group

Description:

RO5317116/F04 active-coated tablet

Treatment:

Drug: dalcetrapib

Drug: atorvastatin

D

Experimental group

Description:

RO4607381/F49 tablet

Treatment:

Drug: dalcetrapib

Drug: atorvastatin