Effect of AKB-6548 on the Pharmacokinetics of Celecoxib

NCT02502500 | Completed Phase 1

• 1 other identifier: AKB-6548-CI-0019
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• PK parameters (Cmax)

  maximum observed plasma concentration (Cmax) for celecoxib

  pre-dose to 48 hours post-dose

• PK parameters (time to reach Cmax )

  time to reach Cmax for celecoxib

  pre-dose to 48 hours post-dose

• PK parameters (t½)

  terminal elimination half-life (t½) for celecoxib

  from pre-dose to 48 hours post-dose

• PK parameters (AUC0-t)

  concentration (AUC0-t) for celecoxib

  pre-dose to 48 hours post-dose

• 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

• PK parameters (AUC0-inf)

  AUC from time 0 to infinity (AUC0-inf) for celecoxib

  from pre-dose to 48 hours post-dose

• PK parameters (CL/F)

  apparent oral clearance (CL/F) for celecoxib

  pre-dose to 48 hours post-dose

• PK parameters (Vz/F)

  apparent volume of distribution during the terminal phase (Vz/F) for celecoxib

  pre-dose to 48 hours post-dose

Secondary Outcomes (3)

• Safety and Tolerability will be measured by vital signs

  up to ten days

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

  up to ten days

• Safety and Tolerability will be measured by clinical assays

  up to ten days

Study Arms (2)

Celecoxib

ACTIVE COMPARATOR

Celecoxib

Drug: Celecoxib

AKB-6548 and Celecoxib

EXPERIMENTAL

AKB-6548; celecoxib

Drug: Celecoxib; Drug: AKB-6548

Interventions

Celecoxib DRUG

Also known as: CELEBREX®

AKB-6548 and Celecoxib; Celecoxib

AKB-6548 DRUG

AKB-6548 and Celecoxib

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akebia Therapeutics: lead

MeSH Terms

Interventions

Celecoxib; vadadustat

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Akebia Therapeutics

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 20, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 14, 2018

Record last verified: 2018-11