Study in Healthy Male Subjects to Evaluate the Effect of Itraconazole and Rifampicin on the PK of Fedovapagon
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|ClinicalTrials.gov Identifier: NCT02440841|
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : July 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Nocturia||Drug: fedovapagon Drug: Itraconazole Drug: rifampicin||Phase 1|
Fedovapagon is a vasopressin V2 receptor agonist in development for the treatment of nocturia. Agonism of the V2 receptor, located in the collecting ducts of the kidney, leads to translocation of aquaporin channels and increased re absorption of water and anti-diuresis.
A number of drugs that are commonly co-prescribed in the population who may present for treatment of nocturia are inhibitors of CYP3A4, including diltiazem, verapamil, erythromycin and clarithromycin and may therefore impact the plasma levels of fedovapagon if co administered.
Conversely, concomitant intake of drugs that are potent CYP3A4 inducers may lead to lower than anticipated plasma concentrations of fedovapagon thus reducing the efficacy of fedovapagon. It is therefore important to assess the effect of CYP3A4 induction on the pharmacokinetic (PK) parameters of fedovapagon.
The study design uses itraconazole as a potent inhibitor of CYP3A4 and, in a separate cohort of subjects, rifampicin as a potent CYP3A4 inducer at doses intended to maximize the potential to demonstrate an interaction.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Center, Open-Label, Single-Sequence, Within-Subject Study In Two Cohorts Of Healthy Male Subjects Comparing Single-Dose Pharmacokinetics Of Fedovapagon Alone And In Combination With A CYP3A4 Inhibitor, Itraconazole, Or A CYP3A4 Inducer, Rifampicin|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: fedovapagon and itraconazole
Two daily doses of fedovapagon and once daily doses of itraconazole
Experimental: fedovapagon and rifampicin
Two daily doses of fedovapagon and once daily doses of rifampicin
- Plasma fedovapagon concentration in presence and absence of co-administered itraconazole or rifampicin [ Time Frame: 10-12 days ]
- Maximum observed plasma concentration (Cmax) [ Time Frame: 10-12 days ]
- Area under the plasma concentration curve versus time curve with extrapolation to infinity (AUC(0-infinity)) [ Time Frame: 10-12 days ]
- Number and type of adverse events [ Time Frame: 12-14 days ]
- Change from baseline in 12-lead ECG [ Time Frame: 12-14 days ]
- Change from baseline in vital signs and physical examination [ Time Frame: 12-14 days ]
- Change from baseline in laboratory assessments [ Time Frame: 12-14 days ]
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): NCT02440841
|PAREXEL Early Phase Clinical Unit Berlin|
|Berlin, Germany, 14050|
|Study Director:||Tshibuabua Kabasela||Parexel|