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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Relative Bioavailability and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants

NCT02480439

Healthy Volunteers

COMPLETED PHASE1

A Single Oral Dose Study to Compare the Bioavailability Between Two Different Tablet Formulations and Assess if There is a Food Effect With the New Formulation

NCT01484964

Pharmacokinetics of ASP015K Bioavailability of ASP015K Healthy Subjects

COMPLETED PHASE1

A Study to Assess the Relative Bioavailability of JNJ64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations

NCT03010059

Healthy

COMPLETED PHASE1

Bioavailability Study of K0706 in Healthy Subjects

NCT03316820

Healthy

COMPLETED PHASE1

Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Tablet Versus JNJ-42756493 Capsule in Healthy Participants

NCT02231489

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment A

AKB-6548

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Treatment B

AKB-6548

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Treatment C

AKB-6548

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

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/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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes