Renal ImpairmentPhase 1NCT00999336

A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment

A Phase 1 study testing Betrixaban in people with Renal Impairment, run by Portola Pharmaceuticals at 1 site in Germany.

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

The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Renal Impairment
What is being tested?: Betrixaban
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteGermany
Study dates: 31 Jul 2009to 28 Feb 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Able to understand and sign the written informed consent.
Subjects should have either normal renal function or have stable renal disease

Who cannot join

Subjects require dialysis
Evidence of active bleeding or bleeding disorder
Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder

Trial locations and contacts

1 site in 1 country.

Germany1 site

APEX GmbH
Munich

Other trials in Germany

About this study

Official title: Pharmacokinetics, Pharmacodynamics, and Tolerability of Betrixaban Administered Orally in Subjects With Normal and Reduced Renal Function.

The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.

Conditions: Renal Impairment
Being tested: Betrixaban
Keywords: Betrixaban, Renal impairment, Healthy, Kidney dysfunction
Medical subject headings: Renal Insufficiency

What participants receive

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

BetrixabanDrug
80 mg betrixaban qd for 8 days

Study groups in NCT00999336
Study group	Role	What they receive
Group H	Active comparator	Healthy subjects matched to the renal impairment groups Receives: Drug: Betrixaban
Group A	Experimental	Patients with mild renal impairment Receives: Drug: Betrixaban
Group B	Experimental	Patients with moderate renal impairment Receives: Drug: Betrixaban
Group C	Experimental	Patients with severe renal impairment Receives: Drug: Betrixaban

What is being measured

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

Area Under The Plasma Concentration-Time Curve From Time Zero To 24 Hours (AUC0-24) Postdose Of Oral Doses Of Betrixaban On Day 8
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2.
Results were reported in nanogram multiplied by hour per milliliter (ng*h/mL).
Measured: Predose up to 168 hours postdose
Maximum Observed Plasma Concentration (Cmax) Following Administration Of Oral Doses Of Betrixaban On Day 8
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2.
Results were reported in nanogram per milliliter (ng/mL).
Measured: Predose, up to 168 hours postdose
Plasma Terminal Elimination Half-Life (T½) Following Administration Of Oral Doses Of Betrixaban On Day 8
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2.
Harmonic mean and Jackknife standard deviation was used to report this outcome and results were reported in hour.
Measured: Predose, up to 168 hours postdose
Total Plasma Clearance (CL/F) Following Administration Of Oral Doses Of Betrixaban On Day 8
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2.
Results were reported in milliliter per minute (mL/min).
Measured: Predose, up to 168 hours postdose
Volume Of Distribution During The Terminal Phase (Vz/F) Following Administration Of Oral Doses Of Betrixaban On Day 8
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2.
Results were reported in liter.
Measured: Predose, up to 168 hours postdose
Percentage Of Dose Excreted In Urine From 0-24 (fe0-24) Postdose Of Oral Doses Of Betrixaban On Day 8
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2.
Results were reported in percentage.
Measured: Predose, up to 24 hours postdose
Percentage Of Betrixaban Bound To Plasma Proteins On Day 8
Blood samples were collected for measurement of plasma protein binding for betrixaban for all participants. Results of protein binding assays were summarized by sample time and eGFR group. Results were reported in percent (%).
Measured: 4 hours Postdose at Day 8
Thrombin Generation Following Administration Of Oral Doses Of Betrixaban On Day 8
Blood samples were collected at the protocol-specified time points. Plasma samples were assayed for measurement of thrombin generation for all participants.
Measured: Day 1: predose; Day 8: 2, 3, 4, 8, 24, and 48 hours postdose
Anti-Factor Xa (fXa) Activity Following Administration Of Oral Doses Of Betrixaban On Day 8
Blood samples were collected at the protocol-specified time points. Plasma samples were assayed for measurement of anti-fXa activity at baseline and steady state for all participants.
Results were reported in international units per milliliter (IU/mL).
Measured: Day 8: 2, 3, 4, 8, 24, and 48 hours postdose

Timeline

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

31 Jul 200928 Feb 2010

First posted21 Oct 2009 (estimated)
Study start31 Jul 2009
Primary completion28 Feb 2010
Study completion28 Feb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal ImpairmentStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00999336
Sponsor's protocol ID: 08-016
Status last verified: Oct 2022
First submitted: 20 Oct 2009
Last updated: 22 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Pharmacodynamics, and Tolerability of Betrixaban Administered Orally in Subjects With Normal and Reduced Renal Function.
ClinicalTrials.gov ID: NCT00999336
Acronym / sponsor ID: 08-016
Conditions: Renal Impairment
Keywords: Betrixaban, Renal impairment, Healthy, Kidney dysfunction
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Portola PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Merck Sharp & Dohme LLC
Study start: 31 Jul 2009 (actual)
Primary completion: 28 Feb 2010 (actual)
Study completion: 28 Feb 2010 (actual)
First posted: 21 Oct 2009 (estimated)
Results: Posted 22 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group H	Active comparator	Drug: BetrixabanHealthy subjects matched to the renal impairment groups
Group A	Experimental	Drug: BetrixabanPatients with mild renal impairment
Group B	Experimental	Drug: BetrixabanPatients with moderate renal impairment
Group C	Experimental	Drug: BetrixabanPatients with severe renal impairment

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Able to understand and sign the written informed consent.
Subjects should have either normal renal function or have stable renal disease

Key exclusion criteria (3 listed)

Subjects require dialysis
Evidence of active bleeding or bleeding disorder
Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Betrixaban80 mg betrixaban qd for 8 days	Drug	Group A, Group B, Group C, Group H

Primary outcome

Area Under The Plasma Concentration-Time Curve From Time Zero To 24 Hours (AUC0-24) Postdose Of Oral Doses Of Betrixaban On Day 8
Time frame: Predose up to 168 hours postdose
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2. Results were reported in nanogram multiplied by hour per milliliter (ng*h/mL).
Maximum Observed Plasma Concentration (Cmax) Following Administration Of Oral Doses Of Betrixaban On Day 8
Time frame: Predose, up to 168 hours postdose
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2. Results were reported in nanogram per milliliter (ng/mL).
Plasma Terminal Elimination Half-Life (T½) Following Administration Of Oral Doses Of Betrixaban On Day 8
Time frame: Predose, up to 168 hours postdose
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2. Harmonic mean and Jackknife standard deviation was used to report this outcome and results were reported in hour.
Total Plasma Clearance (CL/F) Following Administration Of Oral Doses Of Betrixaban On Day 8
Time frame: Predose, up to 168 hours postdose
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2. Results were reported in milliliter per minute (mL/min).
Volume Of Distribution During The Terminal Phase (Vz/F) Following Administration Of Oral Doses Of Betrixaban On Day 8
Time frame: Predose, up to 168 hours postdose
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2. Results were reported in liter.
Percentage Of Dose Excreted In Urine From 0-24 (fe0-24) Postdose Of Oral Doses Of Betrixaban On Day 8
Time frame: Predose, up to 24 hours postdose
Blood and urine samples for pharmacokinetic analysis were collected and determined from the plasma and urine concentrations of betrixaban using non-compartmental procedures in WinNonlin Enterprise Version 5.2. Results were reported in percentage.
Percentage Of Betrixaban Bound To Plasma Proteins On Day 8
Time frame: 4 hours Postdose at Day 8
Blood samples were collected for measurement of plasma protein binding for betrixaban for all participants. Results of protein binding assays were summarized by sample time and eGFR group. Results were reported in percent (%).
Thrombin Generation Following Administration Of Oral Doses Of Betrixaban On Day 8
Time frame: Day 1: predose; Day 8: 2, 3, 4, 8, 24, and 48 hours postdose
Blood samples were collected at the protocol-specified time points. Plasma samples were assayed for measurement of thrombin generation for all participants.
Anti-Factor Xa (fXa) Activity Following Administration Of Oral Doses Of Betrixaban On Day 8
Time frame: Day 8: 2, 3, 4, 8, 24, and 48 hours postdose
Blood samples were collected at the protocol-specified time points. Plasma samples were assayed for measurement of anti-fXa activity at baseline and steady state for all participants. Results were reported in international units per milliliter (IU/mL).

Results and safety

Results posted to the registry on 22 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Renal Function	8	8
Mild Renal Impairment	8	8
Moderate Renal Impairment	8	8
Severe Renal Impairment	8	8

Primary outcome: Area Under The Plasma Concentration-Time Curve From Time Zero To 24 Hours (AUC0-24) Postdose Of Oral Doses Of Betrixaban On Day 8

Time frame: Predose up to 168 hours postdose. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Normal Renal Function n = 8	Mild Renal Impairment n = 8	Moderate Renal Impairment n = 8	Severe Renal Impairment n = 8
Value	437 (237)	807 (254)	1033 (549)	995 (445)

Normal Renal Function vs Mild Renal Impairment: Ratio: 1.89 (90% CI 1.18 to 3.03)
Normal Renal Function vs Moderate Renal Impairment: Ratio: 2.27 (90% CI 1.43 to 3.59)
Normal Renal Function vs Severe Renal Impairment: Ratio: 2.63 (90% CI 1.71 to 4.06)

Population analysed: All participants with varying degrees of renal function who received the study intervention.

Primary outcome: Maximum Observed Plasma Concentration (Cmax) Following Administration Of Oral Doses Of Betrixaban On Day 8

Time frame: Predose, up to 168 hours postdose. Mean (Standard Deviation). Unit: ng/mL

Measure	Normal Renal Function n = 8	Mild Renal Impairment n = 8	Moderate Renal Impairment n = 8	Severe Renal Impairment n = 8
Value	44.0 (24.4)	84.3 (37.0)	108 (59.1)	104 (58.0)

Normal Renal Function vs Mild Renal Impairment: Ratio: 1.88 (90% CI 1.05 to 3.35)
Normal Renal Function vs Moderate Renal Impairment: Ratio: 2.32 (90% CI 1.32 to 4.07)
Normal Renal Function vs Severe Renal Impairment: Ratio: 2.52 (90% CI 1.48 to 4.29)

Population analysed: All participants with varying degrees of renal function who received the study intervention.

Primary outcome: Plasma Terminal Elimination Half-Life (T½) Following Administration Of Oral Doses Of Betrixaban On Day 8

Time frame: Predose, up to 168 hours postdose. Mean (Standard Deviation). Unit: hour

Measure	Normal Renal Function n = 8	Mild Renal Impairment n = 8	Moderate Renal Impairment n = 8	Severe Renal Impairment n = 8
Value	54.4 (9.20)	56.0 (5.09)	60.7 (8.17)	55.6 (5.19)

Population analysed: All participants with varying degrees of renal function who received the study intervention.

Primary outcome: Total Plasma Clearance (CL/F) Following Administration Of Oral Doses Of Betrixaban On Day 8

Time frame: Predose, up to 168 hours postdose. Mean (Standard Deviation). Unit: mL/min

Measure	Normal Renal Function n = 8	Mild Renal Impairment n = 8	Moderate Renal Impairment n = 8	Severe Renal Impairment n = 8
Value	4042 (2376)	1815 (623)	1887 (1468)	1715 (1052)

Population analysed: All participants with varying degrees of renal function who received the study intervention.

Adverse events

Time frame: Day 1 through up to Day 12. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Renal Function	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Mild Renal Impairment	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
Moderate Renal Impairment	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Severe Renal Impairment	1 of 8 (12.5%)	3 of 8 (37.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
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Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Betrixaban in people with Renal Impairment, run by Portola Pharmaceuticals at 1 site in Germany.

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 2 inclusion and 3 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 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

Yes. Results are posted in the registry (first posted 22 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Plasma Concentration-Time Curve From Time Zero To 24 Hours (AUC0-24) Postdose Of Oral Doses Of Betrixaban On Day 8 (time frame: Predose up to 168 hours postdose). The study lists 9 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 NCT00999336.

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 Aug 2023.