A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01622673
First received: June 15, 2012
Last updated: March 7, 2014
Last verified: March 2014
Results First Received: July 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Raltegravir
Drug: TUMS® Ultra Strength
Drug: MINTOX® Maximum Strength

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
Total Total of all reporting groups

Baseline Measures
    RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL     TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL     MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL     RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL     TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL     MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL     Total  
Number of Participants  
[units: participants]
  4     5     4     6     4     4     27  
Age  
[units: years]
Mean ± Standard Deviation
  42.5  ± 10.4     46.6  ± 9.5     36.8  ± 15.4     40.3  ± 10.3     39.8  ± 11.8     40.8  ± 11.6     41.3  ± 10.7  
Gender  
[units: participants]
             
Female     2     1     0     2     0     0     5  
Male     2     4     4     4     4     4     22  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)   [ Time Frame: 12 hours postdose ]

2.  Primary:   Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)   [ Time Frame: 12 hours postdose ]

3.  Primary:   Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose ]

4.  Primary:   Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose ]

5.  Primary:   Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose ]

6.  Primary:   Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose ]

7.  Primary:   Mean Time to Maximum Plasma Concentration (Tmax) of Raltegravir   [ Time Frame: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose ]

8.  Primary:   Number of Participants With Any Clinical or Laboratory Adverse Event (AE)   [ Time Frame: Up to 7 days after the last dose of study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01622673     History of Changes
Other Study ID Numbers: 0518-247
Study First Received: June 15, 2012
Results First Received: July 11, 2013
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration