A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Single-center, Randomized, Open-label, Four Treatments, Four Periods, Four Sequence, Four-way Crossover Study to Explore the Pharmacokinetic Performance of Dalcetrapib and Atorvastatin Fixed Dose Combination Prototype Formulations in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363999
• Other study ID #: WP25642
• Status: Completed
• Phase: Phase 1
• Start date: June 2011
• Est. completion date: July 2011

Study information

• Verified date: December 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• atorvastatin
single dose of atorvastatin on day 1
• dalcetrapib
single dose of dalcetrapib on day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentration of Dalcetrapib Active Form		3 days
Primary	Plasma Concentration of Atorvastatin		3 days
Secondary	Plasma Concentration of Atorvastatin Metabolites	Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma.	3 days
Secondary	Safety: Incidence of Serious Adverse Events		9 weeks