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Clinical Trial Details

Trial ID: L0312
Source ID: NCT04532918
Associated Drug: Verinurad
Title: Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04532918/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: Verinurad|DRUG: Allopurinol|DRUG: Cyclosporine|DRUG: Rifampicin
Outcome Measures: Primary: Geometric Mean Ratio of Maximum Observed Plasma Peak Concentration (Cmax) for Verinurad, Evaluation of a single dose of cyclosporine or rifampicin on the PK of verinurad. Verinurad Cmax ratio of geometric mean of test treatment (verinurad+allopurinol with \[cyclosporine or rifampicin\], relative to reference treatment (verinurad+allopurinol alone) in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Geometric Mean Ratio of Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for Verinurad, Evaluation of a single dose of cyclosporine or rifampicin on the PK of verinurad. Verinurad AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Geometric Mean Ratio of Area Under the Plasma Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUClast) for Verinurad, Evaluation of a single dose of cyclosporine or rifampicin on the PK of verinurad. Verinurad AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period., Days 1 to 5 (pre-dose and post-dose) | Secondary: Geometric Mean Ratio of Cmax for Verinurad Metabolites: M1 and M8, Evaluation of a single dose of cyclosporine or rifampicin on the PK of verinurad metabolites M1 and M8. Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Geometric Mean Ratio of AUCinf for Verinurad Metabolites: M1 and M8, Evaluation of a single dose of cyclosporine or rifampicin on the PK of verinurad metabolites M1 and M8. AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Geometric Mean Ratio of AUClast for Verinurad Metabolites: M1 and M8, Evaluation of a single dose of cyclosporine or rifampicin on the PK of verinurad metabolites M1 and M8. AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period is reported., Days 1 to 5 (pre-dose and post-dose)|Geometric Mean Ratio of Cmax for Allopurinol and Oxypurinol, Evaluation of a single dose of cyclosporine or rifampicin on the PK of allopurinol and oxypurinol. Cmax ratio of geometric means of test geometric means of test treatment, relative to reference treatment in each treatment period is reported., Days 1 to 5 (pre-dose and post-dose)|Geometric Mean Ratio of AUCinf for Allopurinol and Oxypurinol, Evaluation of a single dose of cyclosporine or rifampicin on the PK of allopurinol and oxypurinol. AUCinf ratio of geometric means of test geometric means of test treatment, relative to reference treatment in each treatment period is reported., Days 1 to 5 (pre-dose and post-dose)|Geometric Mean Ratio of AUClast for Allopurinol and Oxypurinol, Evaluation of a single dose of cyclosporine or rifampicin on the PK of allopurinol and oxypurinol. AUClast ratio of geometric means of test geometric means of test treatment, relative to reference treatment in each treatment period is reported., Days 1 to 5 (pre-dose and post-dose)|Area Under Plasma Concentration-time Curve From Zero to 24 Hours Post-dose AUC(0-24) of Verinurad, M1, M8, Allopurinol and Oxypurinol, AUC(0-24) of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Time to Reach Peak or Maximum Plasma Concentration (Tmax) for Verinurad, M1, M8, Allopurinol and Oxypurinol, tmax of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration Time Curve (t½λz) of Verinurad, M1, M8, Allopurinol and Oxypurinol, t½λz of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Terminal Elimination Rate Constant (λz) of Verinurad, M1, M8, Allopurinol and Oxypurinol, λz of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) for Verinurad and Allopurinol, CL/F for verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Mean Residence Time of the Unchanged Drug in the Systemic Circulation (MRTinf) for Verinurad and Allopurinol, MRTinf for verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vss/F) of Verinurad and Allopurinol, Vss/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Based on the Terminal Phase) (Vz/F) of Verinurad and Allopurinol, Vz/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Metabolite:Parent (MP) Cmax Ratios for M1 and M8: Verinurad, Metabolite:parent (MP) Cmax ratios for M1 and M8: verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Metabolite:Parent (MP) AUCinf Ratios for M1 and M8: Verinurad, Metabolite:parent (MP) AUCinf ratios for M1 and M8: verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Metabolite:Parent (MP) AUClast Ratios for M1 and M8: Verinurad, Metabolite:parent (MP) AUClast ratios for M1 and M8: verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period., Days 1 to 5 (pre-dose and post-dose)|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs), Assessment the safety and tolerability of verinurad and allopurinol in combination with cyclosporine or rifampicin, From screening (Day -28 to -2) until Follow-up or Early Termination (7-14 days after last verinurad dose)
Sponsor/Collaborators: Sponsor: AstraZeneca | Collaborators: Parexel
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 14
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: OTHER
Start Date: 2020-09-10
Completion Date: 2020-11-23
Results First Posted: 2023-03-27
Last Update Posted: 2023-03-27
Locations: Research Site, Berlin, 14050, Germany
URL: https://clinicaltrials.gov/show/NCT04532918