Effect of AKB-6548 on the Pharmacokinetics of Celecoxib

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502500
• Other study ID #: AKB-6548-CI-0019
• Status: Completed
• Phase: Phase 1
• Start date: July 2015
• Est. completion date: September 2015

Study information

• Verified date: November 2018
• Source: Akebia Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Celecoxib

• AKB-6548

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akebia Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters (Cmax)	maximum observed plasma concentration (Cmax) for celecoxib	pre-dose to 48 hours post-dose
Primary	PK parameters (time to reach Cmax )	time to reach Cmax for celecoxib	pre-dose to 48 hours post-dose
Primary	PK parameters (t½)	terminal elimination half-life (t½) for celecoxib	from pre-dose to 48 hours post-dose
Primary	PK parameters (AUC0-t)	concentration (AUC0-t) for celecoxib	pre-dose to 48 hours post-dose
Primary	PK parameters (area under the plasma concentration-time curve from 0 to last quantifiable)	area under the plasma concentration-time curve from 0 to last quantifiable	pre-dose to 48 hours post-dose
Primary	PK parameters (AUC0-inf)	AUC from time 0 to infinity (AUC0-inf) for celecoxib	from pre-dose to 48 hours post-dose
Primary	PK parameters (CL/F)	apparent oral clearance (CL/F) for celecoxib	pre-dose to 48 hours post-dose
Primary	PK parameters (Vz/F)	apparent volume of distribution during the terminal phase (Vz/F) for celecoxib	pre-dose to 48 hours post-dose
Secondary	Safety and Tolerability will be measured by vital signs	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	up to ten days
Secondary	Safety and Tolerability will be monitoring of adverse events (AEs)	The safety and tolerability of the single doses of celecoxib alone and in combination with AKB-6548 will be monitored for adverse events (AEs)	up to ten days
Secondary	Safety and Tolerability will be measured by clinical assays	The safety and tolerability of the single doses of celecoxib alone and in combination with AKB-6548 will be monitored for clinical laboratory assays	up to ten days