The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)

NCT00665717 | Completed Phase 1

• 1 other identifier: UMCN-AKF 07.05
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV Infections

Keywords

interaction; statins; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of pravastatin and raltegravir.

  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.

Secondary Outcomes (3)

• 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

  Screening and Days 1, 5, 15, 19, 29 and 33.

• Determination of pharmacokinetic parameters

  at each sampling time

• To evaluate the safety of combined use of pravastatin and raltegravir

  entire trial

Study Arms (3)

A

ACTIVE COMPARATOR

Pravastatin 40 mg QD for 4 days

Drug: Pravastatin

B

ACTIVE COMPARATOR

Raltegravir 400mg BD for 4 days

Drug: Raltegravir

C

EXPERIMENTAL

Interaction between pravastatin and raltegravir

Drug: Pravastatin and raltegravir

Interventions

Pravastatin DRUG

40 mg tablet; QD; 4 days

Also known as: Selektine

A

Raltegravir DRUG

400mg tablet; BD 4 days

Also known as: Isentress

B

Pravastatin and raltegravir DRUG

pravastatin 40mg tablet QD for 4 days; raltegravir 400mg tablet BD for 4 days

Also known as: Selektine and Isentress

C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Location

Related Publications (1)

• van Luin M, Colbers A, van Ewijk-Beneken Kolmer EW, Verweij-van Wissen CP, Schouwenberg B, Hoitsma A, da Silva HG, Burger DM. Drug-drug interactions between raltegravir and pravastatin in healthy volunteers. J Acquir Immune Defic Syndr. 2010 Sep;55(1):82-6. doi: 10.1097/QAI.0b013e3181d9a354.

  PMID: 20395869 RESULT

Related Links

• Publication in Journal of Acquired Immune Deficiency Syndromes; Issue: Volume 55(1), 1 September 2010, pp 82-86

MeSH Terms

Conditions

HIV Infections

Interventions

Pravastatin; Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David M Burger, PharmD PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 24, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: October 19, 2020

Record last verified: 2011-05

Locations

NL (1)