The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00665717
First received: April 23, 2008
Last updated: June 6, 2011
Last verified: May 2011

April 23, 2008
June 6, 2011
May 2008
September 2008   (final data collection date for primary outcome measure)
Plasma concentrations of pravastatin and raltegravir. [ Time Frame: t=0 (predose), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and (24: for pravastatin only) hours post ingestion on Days 4, 18 and 32. Trough level on Day 2, 16 and 30. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00665717 on ClinicalTrials.gov Archive Site
  • To investigate the non-steady state changes in serum low density lipoprotein (LDL) cholesterol secondary to pravastatin use in the presence or absence of raltegravir [ Time Frame: Screening and Days 1, 5, 15, 19, 29 and 33. ] [ Designated as safety issue: Yes ]
  • Determination of pharmacokinetic parameters [ Time Frame: at each sampling time ] [ Designated as safety issue: No ]
  • To evaluate the safety of combined use of pravastatin and raltegravir [ Time Frame: entire trial ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)
The Influence of Raltegravir on Pravastatin Pharmacokinetics in Healthy Volunteers (GRAPPA)

The purpose of this trial is to determine the effect of raltegravir on pravastatin pharmacokinetics and vice versa by intrasubject comparison.

Pravastatin is a first choice statin for HIV-infected patients. Therefore, raltegravir and pravastatin are expected to be co-administered frequently in HIV-infected patients.Since both agents share the same metabolic pathway, there is a potential for a pharmacokinetic drug-drug interaction.

Because co-administration will be indicated in many HIV-infected patients, it is essential to investigate this potential interaction.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Pravastatin
    40 mg tablet; QD; 4 days
    Other Name: Selektine
  • Drug: Raltegravir
    400mg tablet; BD 4 days
    Other Name: Isentress
  • Drug: Pravastatin and raltegravir
    pravastatin 40mg tablet QD for 4 days; raltegravir 400mg tablet BD for 4 days
    Other Name: Selektine and Isentress
  • Active Comparator: A
    Pravastatin 40 mg QD for 4 days
    Intervention: Drug: Pravastatin
  • Active Comparator: B
    Raltegravir 400mg BD for 4 days
    Intervention: Drug: Raltegravir
  • Experimental: C
    Interaction between pravastatin and raltegravir
    Intervention: Drug: Pravastatin and raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is at least 18 and not older than 55 years of age.
  • Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day.
  • Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2.
  • Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
  • Subject is in good age-appropriate health condition.
  • Subject has a normal blood pressure and pulse rate.

Exclusion Criteria:

  • Documented history of sensitivity/idiosyncrasy to medicinal products or exci-pients.
  • Positive HIV test.
  • Positive hepatitis B or C test.
  • Pregnant female or breast-feeding female.
  • Therapy with any drug.
  • Relevant history or presence of pulmonary disorders (especially COPD), car-diovascular disorders, neurological disorders (especially seizures and mi-graine), gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
  • Fasting triglyceride levels > 8.0 mmol/L
  • Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
  • History of or current abuse of drugs, alcohol or solvents.
  • Inability to understand the nature and extent of the trial and the procedures required.
  • Participation in a drug trial within 60 days prior to the first dose.
  • Donation of blood within 60 days prior to the first dose.
  • Febrile illness within 3 days before the first dose
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00665717
UMCN-AKF 07.05
No
Dr. D.M. Burger, hospital pharmacist, Radboud University Nijmegen Medical Centre
Radboud University
Merck Sharp & Dohme Corp.
Principal Investigator: David M Burger, PharmD PhD Radboud University
Radboud University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP