A Two Way Cross Over Pharmacokinetic Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT01841593
First received: April 16, 2013
Last updated: September 23, 2014
Last verified: September 2014
Results First Received: July 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV
Interventions: Drug: Raltegravir
Drug: Amlodipine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group A (Raltegravir Then Amlodipine) DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
Group B (Amlodipine Then Raltegravir) DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID

Participant Flow for 3 periods

Period 1:   First Intervention (Days 1 to 7)
    Group A (Raltegravir Then Amlodipine)     Group B (Amlodipine Then Raltegravir)  
STARTED     12     7  
COMPLETED     12     6  
NOT COMPLETED     0     1  
Protocol Violation                 0                 1  

Period 2:   Second Intervention (Days 8 to 14)
    Group A (Raltegravir Then Amlodipine)     Group B (Amlodipine Then Raltegravir)  
STARTED     12     6  
COMPLETED     11     6  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  

Period 3:   Third Intervention (Days 15 to 21)
    Group A (Raltegravir Then Amlodipine)     Group B (Amlodipine Then Raltegravir)  
STARTED     11     6  
COMPLETED     11     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
All enrolled participants who completed at least two of three pharmacokinetic sessions for comparison were included in the analysis.

Reporting Groups
  Description
Group A DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
Group B DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
Total Total of all reporting groups

Baseline Measures
    Group A     Group B     Total  
Number of Participants  
[units: participants]
  11     6     17  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     6     17  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     10     3     13  
Male     1     3     4  



  Outcome Measures
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1.  Primary:   Maximum Observed Concentration (Cmax) of Raltegravir and Amlodipine Without and With Co-administration of the Other Studied Drug.   [ Time Frame: Day 7 of each intervention (0 (pre-dose), 2, 4, 8 and 12 hours post dose (both drugs) and 24 hours post dose (amlodipine only)) ]

2.  Primary:   Raltegravir C12h   [ Time Frame: 12 hours post-dose on day 7 of daily dosing. ]

3.  Primary:   Amlodipine C24h   [ Time Frame: 12 hours post-dose on day 7 of daily dosing. ]

4.  Primary:   Raltegravir AUC(0-12h )   [ Time Frame: Post dose after day 7 of daily dosing ]

5.  Primary:   Amlodipine AUC(0-24h)   [ Time Frame: Post-dose on day 7 of daily dosing ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Marta Boffito
Organization: SSAT Research, Chelsea & Westminster Hospital
phone: +442033155601
e-mail: marta.boffito@chelwest.nhs.uk


No publications provided


Responsible Party: St Stephens Aids Trust
ClinicalTrials.gov Identifier: NCT01841593     History of Changes
Other Study ID Numbers: SSAT 051
Study First Received: April 16, 2013
Results First Received: July 14, 2014
Last Updated: September 23, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency