Effect of Antacids on the Pharmacokinetics of Raltegravir

NCT00944307 | Completed Phase 1 FDA Drug

• 1 other identifier: 09-0475
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test whether there is a drug interaction between raltegravir (a medicine used to treat the human immunodeficiency virus or HIV) and antacids.

Conditions

HIV Infections

Keywords

HIV; antiretroviral; drug interaction; human immunodeficiency virus

Outcome Measures

Primary Outcomes (1)

• Raltegravir AUC with and without an antacid

  0-48 hours

Secondary Outcomes (1)

• Raltegravir Cmax with and without an antacid

  0-48 hours

Study Arms (2)

raltegravir alone

ACTIVE COMPARATOR

Subjects will receive a single dose of 400 mg raltegravir orally

Drug: raltegravir

raltegravir plus antacid

EXPERIMENTAL

Subjects will receive a single dose of 400mg raltegravir orally simultaneously with an antacid

Drug: raltegravir; Drug: antacid

Interventions

raltegravir DRUG

raltegravir 400mg orally once

Also known as: Isentress

raltegravir alone; raltegravir plus antacid

antacid DRUG

aluminum, magnesium, simethicone-containing antacid 30mL orally once

Also known as: Isentress, Maalox Plus Extra Strength

raltegravir plus antacid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Absence of HIV-1 infection as documented by any licensed ELISA test kit within 21 days prior to study entry.
• Age greater than or equal to 18 but less than or equal to 60 years.
• Ability and willingness to give written informed consent.
• Within 30% (+/-) of ideal body weight and total body weight of ≥ 50 kg.
• Hematology, Metabolic Profile, Renal, and Hepatic Function tests all within normal limits.
• Creatine kinase (CK) less than 3 times the upper limit of normal

You may not qualify if:

• Pregnancy or breast-feeding.
• Women and men of reproductive potential who are actively engaging in sexual activity or assisted reproductive technology with the intent of pregnancy.
• Allergy/sensitivity to raltegravir.
• Allergy/sensitivity to antacids.
• Active drug or alcohol abuse or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. While on study, subjects will be instructed not to consume alcohol for 48 hours prior the screening visit, and for the 24 hours preceding the intensive pharmacokinetic (PK) study visits and for 24 hours following the completion of the study visits.
• Any medical condition that, in the opinion of the investigator, would interfere with the subject's ability to participate in this protocol.
• Participation in any investigational drug studies within 30 days prior to study entry.
• History of or active cardiovascular, renal, hematologic, hepatic, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease(s). This is inclusive of chronic illnesses such as hypertension, coronary artery disease, arthritis, diabetes, any chronic gastrointestinal conditions that might interfere with drug absorption.
• Use of investigational, prescription, and over-the-counter medications within 14 days of study entry with the following exceptions: aspirin, acetaminophen, ibuprofen, and oral contraceptives

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Raltegravir Potassium; Antacids; aluminum hydroxide, magnesium hydroxide, drug combination

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; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Gastrointestinal Agents; Therapeutic Uses

Study Officials

• Jennifer J Kiser, PharmD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 23, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 28, 2017

Record last verified: 2017-06

Locations

US (1)