Pharmacokinetic Drug-drug Interaction Study Between RaltEgravir and CITALopram in Healthy Subjects (RECITAL). (RECITAL)
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|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: isentress
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978782
|CRCN Radboud university medical center|