Effect of AKB-6548 on the Pharmacokinetics of Celecoxib

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

To assess the single dose pharmacokinetics (PK) of celecoxib in healthy subjects when administered alone and following multiple daily doses of AKB-6548.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Akebia Therapeutics
• Treatments: Celecoxib

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.