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Effect of AKB-6548 on the Pharmacokinetics of Celecoxib

Information source: Akebia Therapeutics
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Celecoxib (Drug); AKB-6548 (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Akebia Therapeutics

Official(s) and/or principal investigator(s):
Akshay Buch, Study Chair, Affiliation: Akebia Therapeutics, Inc.

Overall contact:
Akebia Call Center, Phone: 1-855-252-6548, Email: AKB6548@akebia.com

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome:

PK parameters (Cmax)

PK parameters (time to reach Cmax )

PK parameters (t½)

PK parameters (AUC0-t)

PK parameters (area under the plasma concentration-time curve from 0 to last quantifiable)

PK parameters (AUC0-inf)

PK parameters (CL/F)

PK parameters (Vz/F)

Secondary outcome:

Safety and Tolerability will be measured by vital signs

Safety and Tolerability will be monitoring of adverse events (AEs)

Safety and Tolerability will be measured by clinical assays

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

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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.

Locations and Contacts

Akebia Call Center, Phone: 1-855-252-6548, Email: AKB6548@akebia.com

Additional Information

Starting date: July 2015
Last updated: July 17, 2015

Page last updated: August 20, 2015

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