Relative Bioavailability of Two Formulations of AKB-6548 and the Food Effect of a New Tablet in Healthy Adult Subjects

NCT02412449 | Completed Phase 1

• 1 other identifier: AKB-6548-CI-0013
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to compare the PK parameters of a single dose of a test tablet formulation of AKB-6548 relative to a single dose of the reference AKB-6548 tablet formulation, both treatments administered without food, and to compare the PK parameters of the test tablet formulation given under fed and fasted conditions.

Conditions

Healthy

Keywords

Pharmacokinetics; Anemia; Chronic kidney disease; CKD; Renal impairment; Chronic renal insufficiency; Ferrous sulfate; Iron; End stage renal disease; Dialysis; Oral anemia treatment; Bioavailability; Erythropoietin; Hypoxia-inducible factor; Volunteers

Outcome Measures

Primary Outcomes (6)

• Bioavailability endpoints: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t) of AKB-6548

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose

• Bioavailability endpoints: Area under the concentration time curve from time 0 to infinity (AUC 0-inf) of AKB-6548

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose

• Bioavailability endpoints: Maximum observed plasma concentration (Cmax) of AKB-6548

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose

• Food Effect Endpoint: AKB-6548 AUC 0-t for the fed versus fasted administration of AKB-6548 tablets

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose

• Food Effect Endpoint: AKB-6548 AUC 0-inf for the fed versus fasted administration of AKB-6548 tablets

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose

• Food Effect Endpoint: AKB-6548 Cmax for the fed versus fasted administration of AKB-6548 tablets

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose

Secondary Outcomes (8)

• PK Parameters of AKB-6548: Maximum observed plasma concentration (Cmax)

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose

• PK Parameters of AKB-6548: Time to reach Cmax (Tmax)

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose

• PK Parameters of AKB-6548: Terminal elimination rate constant (λz)

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose

• PK Parameters of AKB-6548: Terminal elimination half-life (t1/2)

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose

• PK Parameters of AKB-6548: Area under the plasma concentration-time curve from 0 to last quantifiable concentration (AUC 0-t)

  Multiple timepoint evaluations from pre-dose to 24 hours post-dose

Study Arms (3)

Treatment A

EXPERIMENTAL

AKB-6548

Drug: AKB-6548 tablet, reference formulation given in the fasted state

Treatment B

EXPERIMENTAL

AKB-6548

Drug: AKB-6548 tablet, test formulation given in the fasted state.

Treatment C

EXPERIMENTAL

AKB-6548

Drug: AKB-6548 tablet, test formulation given in the fed state

Interventions

AKB-6548 tablet, reference formulation given in the fasted state DRUG

Treatment A

AKB-6548 tablet, test formulation given in the fasted state. DRUG

Treatment B

AKB-6548 tablet, test formulation given in the fed state DRUG

Treatment C

Eligibility Criteria

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

You may qualify if:

• Healthy male and female subjects between 18 and 55 years of age, inclusive, and with a body mass index between 18 and 30 kg/m2, inclusive.

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/min
• Known active cancer (except non-melanoma skin 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.
• 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

Study Sites (1)

Unknown Facility

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic

Interventions

vadadustat

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Akebia Therapeutics

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 9, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

US (1)