A Study in Evaluating Bioequivalence Between Test and Ref... | NCT03639155

Studies
A Study in Evaluating Bioequivalence Between Test and Reference Formulations of Vadadustat Tablets in Healthy Adults

NCT03639155

Sponsor

Akebia Therapeutics

Status

Completed

Last Update Posted

Mar 22, 2019Actual

Enrollment

50Actual

Phase

Phase 1

Conditions

Healthy

Interventions

vadadustat reference tablets
vadadustat test tablets

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2018Actual

Primary Completion Date

May 23, 2018Actual

Completion Date

May 23, 2018Actual

First Submitted Date

Jun 12, 2018

First Submission Date that Met QC Criteria

Aug 16, 2018

First Posted Date

Aug 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2019

Last Update Posted Date

Mar 22, 2019Actual

Description Module

Brief Summary

This study is to assess the bioequivalence of a test formulation of vadadustat (A) compared to a reference formulation of vadadustat (B)

Detailed Description

This is a randomized, open-label, single-dose, two-period crossover study in healthy adults to assess the bioequivalence of a test formulation of vadadustat compared to the reference formulation of vadadustat. Blood samples for vadadustat PK will be collected at pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 32, 40, and 48 hours post-dose.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regimen A	Experimental	vadadustat reference tablets	Drug: vadadustat reference tablets
Regimen B	Experimental	vadadustat test tablets	Drug: vadadustat test tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vadadustat reference tablets	Drug	oral tablet	Regimen A	AKB-6548

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)		Baseline visit, 48 hours
Area under plasma concentration-time curve from 0 to infinity (AUCinf)		Baseline visit, 48 hours
Area under plasma concentration-time curve from 0 to last sampling point (AUCall)		Baseline visit, 48 hours
Observed maximum concentration (Cmax)		Baseline visit, 48 hours

Secondary Outcomes

Measure	Description	Time Frame
Time to reach Cmax		Baseline visit, 48 hours
Time to reach Tmax		Baseline visit, 48 hours
Mean residence time (MRT)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between 18 and 55 years of age, inclusive, at time of informed consent.
Healthy subjects per Investigator judgment as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations.
Minimum weight of 45 kg with Body mass index (BMI) between 18 and 29.5 kg/m2, inclusive.
Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure
Willing and able to comply with the requirements of the study protocol.

Exclusion Criteria:

Current or past history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease, history of cancer (except non-melanoma skin cancer) or history of chemotherapy use.
Any surgical or medical condition or history that may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to gastric bypass surgery or gastric or duodenal ulcers.
History of severe allergic or anaphylactic reactions.
Chronic daily medication use.
History of drug abuse
Excessive alcohol consumption
Smoking and the use of nicotine-containing products
Consumption of grapefruit or grapefruit juice, pomelo, star fruit, Seville or Moro (blood) orange, or their associated products
Participation in another clinical trial or exposure to any investigational agent.
Donation of blood or significant blood loss or plasma donation.
Any condition that would interfere with the ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the patient at undue risk.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided