Pharmacokinetic Drug-drug Interaction Study Between RaltEgravir and CITALopram in Healthy Subjects (RECITAL). (RECITAL)
|ClinicalTrials.gov Identifier: NCT01978782|
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : July 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV Depression||Drug: raltegravir Drug: citalopram||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetic Drug-drug Interaction Study Between RaltEgravir and CITALopram in Healthy Subjects (RECITAL).|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Active Comparator: raltegravir alone
raltegravir 400 mg BID for 5 days
Other Name: isentress
Active Comparator: citalopram alone
citalopram 10 mg QD for 3 days, followed by citalopram 20 mg QD for 13-14 days
Experimental: raltegravir + citalopram
raltegravir 500 mg BID and citalopram 20 mg QD for 5 days
Other Name: isentressDrug: citalopram
- raltegravir AUC and citalopram AUC [ Time Frame: at steady state: day 5 of raltegravir treatment and day 16 or later for citalopram ]
To assess the effect of multiple dose citalopram on the steady state pharmacokinetics of raltegravir and vice versa by intrasubject comparison in healthy subjects.
- The comparison of steady state raltegravir (400 mg BID for 5 days) pharmacokinetics (AUC0-12h, Cmax, C12h) with steady state citalopram (20 mg QD) vs. raltegravir alone by intrasubject comparison.
- The comparison of steady state citalopram (20 mg QD) pharmacokinetics (AUC0-24h, Cmax, C24h) with steady state raltegravir (400 mg BID) vs. citalopram alone by intrasubject comparison.
- Adverse Events [ Time Frame: up to approximately 13 weeks (from screening until the last study visit) ]Adverse events will be scored and laboratory measurements for safety will be collected frequently from screening onwards (maximum 4 weeks before the start of the study) until the last study visit (Day 60) or longer if applicable.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978782
|CRCN Radboud university medical center|