A Two Way Cross Over Pharmacokinetic Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers
The purpose of the study is to look at the levels of an HIV medication (raltegravir) in the blood, and how it is affected if raltegravir is taken at the same time as another medicine for high blood pressure (amlodipine). Many patients with HIV will also have high blood pressure, so it is important to know which drugs for each of these conditions can be taken together without affecting how well they work individually.
Over a 3 week period, subjects will take amlodipine for 2 weeks, and raltegravir for 2 weeks, with the middle week being on both drugs. The investigators will look at and compare the levels of these two drugs in the blood after subjects have taken them separately and both together.
The duration of involvement in the study will be up to 22 days plus a screening visit which will take place up to 4 weeks prior to the start of the study, and a follow up visit which takes place 7-14 days after the last dose of study medication.
This study is randomised (like flipping a coin) into two groups who will receive the same study medications, but in a different order (this is known as a crossover study). The subject and the study doctor will know which study medications you are taking at all times during the study.
The subject will need to stay at the study centre all day (12-14 hours) on three occasions during the study.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
- Pharmacokinetics of raltegravir and amlodipine co-administration [ Time Frame: 21/22 days ] [ Designated as safety issue: Yes ]
To investigate the pharmacokinetics of raltegravir and amlodipine co-administration. The pharmacokinetic parameters calculated for raltegravir and amlodipine will be trough concentration (Ctrough), defined as the concentration at 24 hours after the observed drug dose, the maximum observed plasma concentration (Cmax), elimination half-life (t1/2), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration-time curve from 0-24 hours after dosing (AUC0-24h).
All pharmacokinetic parameters will be calculated using non-compartmental modeling techniques (WinNonlin®) and all statistical calculations performed and analyzed using SAS version 9.1 or SPSS V17.0.
- Safety and tolerability of raltegravir and amlodipine co-administration [ Time Frame: 21/22 days ] [ Designated as safety issue: Yes ]
To investigate the safety and tolerability of raltegravir and amlodipine co-administration. Adverse events observed by the Investigator, or reported by the subject, and any remedial action taken, will be recorded in the subject's CRF and should be verifiable in the subject's notes throughout the study. The nature of each event, time of onset after drug administration, duration and severity will be documented together with the Investigator's opinion of the causal relationship to the treatment (unrelated, unlikely, possible, probable, and definite).
All patients, whether withdrawn prematurely or not, will be included in the safety analysis. All safety data and adverse events will be summarised.
|Study Start Date:||April 2013|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: 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
|Drug: Raltegravir Drug: Amlodipine|
Experimental: 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
|Drug: Raltegravir Drug: Amlodipine|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01841593
|St Stephen's AIDS Trust|
|London, United Kingdom, SW10 9TH|