Effect of AKB-6548 on the Pharmacokinetics of Celecoxib
- Registration Number
- NCT02502500
- Lead Sponsor
- Akebia Therapeutics
- Brief Summary
To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when administered alone and following multiple daily doses of AKB-6548.
- Detailed Description
To assess the single dose plasma pharmacokinetics (PK), safety, and tolerability of celecoxib in healthy subjects with CYP2C9 extensive metabolizer (EM) genotype when administered alone and following multiple daily doses of AKB-6548.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
- Healthy male subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/sq.meters, inclusive.
- Subjects with the following genotype based upon pharmacogenetic testing results: CYP2C9 EM: *1*1.
- Current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease.
- Positive serology results for HBsAg, HCV, and HIV at Screening.
- Significant renal impairment as evidenced by an estimated glomerular filtration rate (eGFR) of <65 mL/minute/1.73 sq.meters.
- Known hypersensitivity to celecoxib or sulfonamides.
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- Known active cancer or history of chemotherapy use within the previous 24 months.
- Current or past history of gastric or duodenal ulcers or other diseases of the GI tract (including gastric bypass surgeries) that could interfere with absorption of study drug.
- Current or past history of gastrointestinal bleeding.
- Any history of alcohol or drug abuse within the previous year prior to Screening.
- Subjects with a known history of smoking and/or have used nicotine or nicotine containing products within the past 6 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Celecoxib Celecoxib Celecoxib AKB-6548 and Celecoxib AKB-6548 AKB-6548; celecoxib AKB-6548 and Celecoxib Celecoxib AKB-6548; celecoxib
- Primary Outcome Measures
Name Time Method PK parameters (time to reach Cmax ) pre-dose to 48 hours post-dose time to reach Cmax for celecoxib
PK parameters (AUC0-inf) from pre-dose to 48 hours post-dose AUC from time 0 to infinity (AUC0-inf) for celecoxib
PK parameters (Cmax) pre-dose to 48 hours post-dose maximum observed plasma concentration (Cmax) for celecoxib
PK parameters (AUC0-t) pre-dose to 48 hours post-dose concentration (AUC0-t) for celecoxib
PK parameters (t½) from pre-dose to 48 hours post-dose terminal elimination half-life (t½) for celecoxib
PK parameters (area under the plasma concentration-time curve from 0 to last quantifiable) pre-dose to 48 hours post-dose area under the plasma concentration-time curve from 0 to last quantifiable
PK parameters (CL/F) pre-dose to 48 hours post-dose apparent oral clearance (CL/F) for celecoxib
PK parameters (Vz/F) pre-dose to 48 hours post-dose apparent volume of distribution during the terminal phase (Vz/F) for celecoxib
- Secondary Outcome Measures
Name Time Method Safety and Tolerability will be measured by vital signs up to ten days The safety and tolerability of the single doses of celecoxib alone and in combination with AKB-6548 will be monitored for vital signs, clinical laboratory assays
Safety and Tolerability will be measured by clinical assays up to ten days The safety and tolerability of the single doses of celecoxib alone and in combination with AKB-6548 will be monitored for clinical laboratory assays
Safety and Tolerability will be monitoring of adverse events (AEs) up to ten days The safety and tolerability of the single doses of celecoxib alone and in combination with AKB-6548 will be monitored for adverse events (AEs)