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OpenTrials
Completed

NCT Number: NCT01363999

A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Christchurch, 8011, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

single dose of atorvastatin on day 1

Dalcetrapib

Drug

single dose of dalcetrapib on day 1

Primary outcomes

  1. Plasma Concentration of Dalcetrapib Active Form

    Time frame: 3 days

  2. Plasma Concentration of Atorvastatin

    Time frame: 3 days

Secondary outcomes

  1. Plasma Concentration of Atorvastatin Metabolites

    Time frame: 3 days

    Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma.

  2. Safety: Incidence of Serious Adverse Events

    Time frame: 9 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 2, 2011
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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