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Hepatic ImpairmentPhase 1NCT03799848

A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function

A Phase 1 study testing Vadadustat in people with Hepatic Impairment, run by Akebia Therapeutics at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase I open-label study to evaluate the pharmacokinetic (PK) profile of a single oral dose of vadadustat in subjects with hepatic impairment(HI) compared to healthy matched control subjects with normal hepatic function. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Impairment
What is being tested?
Vadadustat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
12 Jun 2018to 18 Oct 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female subjects between ≥18 years and ≤70 years of age
  • Have a body weight ≥45 kg and body mass index (BMI) ≥18.5 kg/m2 to 40.0 kg/m2
  • Additional Group-Specific Inclusion Criteria:
  • Group 1 (Moderate Hepatic Impairment Subjects):
  • Presence of Moderate hepatic impairment (Child-Pugh Class B)
  • Group 2 (Normal Hepatic Function Subjects):
Show all 9Show fewer
  • Normal hepatic function
  • Group 3 (Mild Hepatic Impairment Subjects):
  • Presence of mild hepatic impairment ( Child-Pugh Class A)

Who cannot join

  • Renal impairment ≥ Stage 3 (estimated glomerular filtration rate [eGFR] <60 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) study equation)
  • Any history of active malignancy within 2 years prior to or during screening, except for treated basal cell carcinoma of skin, curatively resected squamous cell carcinoma of skin, or cervical carcinoma in situ; any history of tuberculosis and/or prophylaxis for tuberculosis
  • Positive test for human immunodeficiency virus (HIV) antibody at Screening.
  • Hepatic or other organ or cell transplant
  • Subjects with alcoholic cirrhosis must be sober for a minimum of 6 months

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Prism Clinical Research

    Saint Paul, Minnesota, 55114

  • American Research Corporation at the University of Texas Liver Institute

    San Antonio, Texas, 78215

Other trials in United States

About this study

Official title: Phase 1, Open-Label, Parallel-Group, Pharmacokinetic Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function

This is a Phase I open-label study to evaluate the pharmacokinetic (PK) profile of a single oral dose of vadadustat in subjects with hepatic impairment(HI) compared to healthy matched control subjects with normal hepatic function.

Read the detailed description

This is an open label, parallel-group, single dose, Phase 1 study to evaluate the PK profile, safety, and tolerability of a single oral 450 mg dose of vadadustat in subjects with hepatic impairment relative to control subjects with normal hepatic function. The study will enroll up to 24 subjects in 3 groups of 8 subjects at 2 study sites. Blood samples for vadadustat PK and its metabolites will be collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 60, and 72 hours post-dose.

Being tested
Vadadustat
Keywords
Hepatic impairment, Healthy subjects, Child-pugh, Vadadustat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VadadustatDrug

    Also called AKB-6548

    Oral tablet

Study groups in NCT03799848
Study groupRoleWhat they receive
VadadustatExperimentalGroup 1: Subjects with moderately impaired hepatic function (Child-Pugh Class B) Group 2: Normal healthy volunteers Group 3: Subjects with mildly impaired hepatic function (Child-Pugh Class A)
Receives: Drug: Vadadustat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the concentration-time curve from dosing to last measurable concentration (AUClast)

    Measured: Day 1, Day 4

  2. Area under the concentration-time curve from dosing to infinity (AUCinf)

    Measured: Day 1, Day 4

  3. Observed maximum concentration (Cmax).

    Measured: Day 1, Day 4

Secondary outcomes (18)

  1. Time to reach Cmax of vadadustat

    Measured: Day 1, Day 4

  2. Apparent total body clearance (CL/F) of vadadustat

    Measured: Day 1, Day 4

  3. Apparent volume of distribution (Vd/F) of vadadustat

    Measured: Day 1, Day 4

  4. Terminal half-life (t1/2) of vadadustat

    Measured: Day 1, Day 4

  5. Time to reach Tmax of vadadustat

    Measured: Day 1, Day 4

  6. Assessment of Treatment-Emergent Adverse Events (TEAEs) as reported by study subjects

    Measured: Up to 9 Weeks

  7. Cmax related to free drug (Cmax, free) of Vadadustat Unbound

    Measured: Day 1, Day 4

  8. AUClast related to free drug (AUClast, free) of Vadadustat Unbound

    Measured: Day 1, Day 4

  9. AUCinf related to free drug (AUCinf, free) of Vadadustat Unbound

    Measured: Day 1, Day 4

  10. CL/F related to free drug (CL/Ffree) of Vadadustat Unbound

    Measured: Day 1, Day 4

  11. Terminal half-life (t1/2) of Vadadustat Unbound

    Measured: Day 1, Day 4

  12. The area under the concentration-time curve from dosing to last measurable concentration (AUClast) of Vadadustat metabolites

    Measured: Day 1, Day 4

  13. The area under the concentration-time curve from dosing to infinity (AUCinf) of Vadadustat metabolite

    Measured: Day 1, Day 4

  14. Time to reach Cmax of vadadustat metabolites

    Measured: Day 1, Day 4

  15. Terminal half-life (t1/2) of Vadadustat metabolites

    Measured: Day 1, Day 4

  16. Renal clearance (CLr) of Vadadustat/metabolite(s) Urine

    Measured: Day 1, Day 4

  17. Cumulative amount of drug excreted (Ae) of Vadadustat/metabolite(s) Urine

    Measured: Day 1, Day 4

  18. Cumulative fraction of drug excreted (Fe) of Vadadustat/metabolite(s) Urine

    Measured: Day 1, Day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2019
  2. Study start12 Jun 2018
  3. Primary completion18 Oct 2018
  4. Study completion18 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03799848
Sponsor's protocol ID
AKB-6548-CI-0024
Status last verified
Mar 2019
First submitted
27 Dec 2018
Last updated
22 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vadadustat in people with Hepatic Impairment, run by Akebia Therapeutics at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the concentration-time curve from dosing to last measurable concentration (AUClast) (time frame: Day 1, Day 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03799848.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.

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