Clinical trial NCT02502500: Effect of AKB-6548 on the Pharmacokinetics of Celecoxib
Official title: An Open-label Study in Healthy Subjects to Assess the Effect of Once-daily Multiple Dosing of AKB-6548 on the Pharmacokinetics of the CYP2C9 Substrate Celecoxib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Akebia Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-07-20
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: PK parameters (Cmax)
timeFrame: pre-dose to 48 hours post-dose
measure: PK parameters (time to reach Cmax )
timeFrame: pre-dose to 48 hours post-dose
measure: PK parameters (t½)
timeFrame: from pre-dose to 48 hours post-dose
measure: PK parameters (AUC0-t)
timeFrame: pre-dose to 48 hours post-dose
measure: PK parameters (area under the plasma concentration-time curve from 0 to last quantifiable)
timeFrame: pre-dose to 48 hours post-dose
measure: PK parameters (AUC0-inf)
timeFrame: from pre-dose to 48 hours post-dose
measure: PK parameters (CL/F)
timeFrame: pre-dose to 48 hours post-dose
measure: PK parameters (Vz/F)
timeFrame: pre-dose to 48 hours post-dose
Secondary outcomes:
measure: Safety and Tolerability will be measured by vital signs
timeFrame: up to ten days
measure: Safety and Tolerability will be monitoring of adverse events (AEs)
timeFrame: up to ten days
measure: Safety and Tolerability will be measured by clinical assays
timeFrame: up to ten days
Other outcomes:
Locations:
Study officials:
affiliation: Sponsor GmbH
name: Akebia Therapeutics
role: STUDY_DIRECTOR
References: