OncologyPhase 1NCT02521376
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
A Phase 1 study testing Entospletinib in people with Oncology, run by Gilead Sciences at 6 sites in 3 countries.
Trial summary
The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate) relative to matched, healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oncology
- What is being tested?
- Entospletinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 16 Nov 2015to 25 Oct 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Calculated body mass index from 18 to 40 kg/m^2
- Not pregnant
- Normal electrocardiogram
- Participants with impaired liver function must be sufficiently healthy based upon medical history and physical examination, vital signs, and screening laboratory evaluations.
Who cannot join
- Participation in another clinical study (current or within last 30 days)
- HIV, hepatitis B virus, or active hepatitis C virus infection
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
Clinical Pharmacology of Miami, Inc. (CPMI)
Miami, Florida
DaVita Clinical Research
Minneapolis, Minnesota
Orlando Clinical Research Center
Orlando, Florida
The Texas Liver Institute
San Antonio, Texas
About this study
Official title: A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics of Entospletinib in Subjects With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate) relative to matched, healthy controls.
- Conditions
- Oncology
- Being tested
- Entospletinib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntospletinibDrug
Also called GS-9973
Entospletinib 100 mg tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Moderate Hepatic Impairment) | Experimental | Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5. Receives: Drug: Entospletinib |
| Cohort 2 (Severe Hepatic Impairment) | Experimental | Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5. Receives: Drug: Entospletinib |
| Cohort 3 (Mild Hepatic Impairment) | Experimental | Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5. Receives: Drug: Entospletinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) Parameter: AUCtau of ENTO
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Measured: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60, 72, 84, and 96 hours postdose on Day 5
Pharmacokinetic (PK) Parameter: Cmax of ENTO
Cmax is defined as the maximum concentration of drug.
Measured: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60, 72, 84, and 96 hours postdose on Day 5
Secondary outcomes (2)
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
TEAEs are defined as events that meet one of the following criteria:
- Any adverse events (AEs) with onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or
- Any AEs leading to premature discontinuation of study drug.
Measured: Baseline up to Day 9 plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each subject.
Measured: Baseline up to Day 9 plus 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start16 Nov 2015
- Primary completion25 Oct 2017
- Study completion25 Oct 2017
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 OncologyStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521376
- Sponsor's protocol ID
- GS-US-339-1631
- Other IDs
- 2016-003266-98, 2016
- Status last verified
- May 2019
- First submitted
- 10 Aug 2015
- Last updated
- 26 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics of Entospletinib in Subjects With Normal and Impaired Hepatic Function
- ClinicalTrials.gov ID
- NCT02521376
- Acronym / sponsor ID
- GS-US-339-1631
- Conditions
- Oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 26 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate) relative to matched, healthy controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Moderate Hepatic Impairment) | Experimental | Drug: EntospletinibEntospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5. |
| Cohort 2 (Severe Hepatic Impairment) | Experimental | Drug: EntospletinibEntospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5. |
| Cohort 3 (Mild Hepatic Impairment) | Experimental | Drug: EntospletinibEntospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Calculated body mass index from 18 to 40 kg/m^2
- Not pregnant
- Normal electrocardiogram
- Participants with impaired liver function must be sufficiently healthy based upon medical history and physical examination, vital signs, and screening laboratory evaluations.
Key exclusion criteria (3 listed)
- Participation in another clinical study (current or within last 30 days)
- HIV, hepatitis B virus, or active hepatitis C virus infection
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| EntospletinibAlso: GS-9973Entospletinib 100 mg tablet administered orally | Drug | Cohort 1 (Moderate Hepatic Impairment), Cohort 2 (Severe Hepatic Impairment), Cohort 3 (Mild Hepatic Impairment) |
Primary outcome
Pharmacokinetic (PK) Parameter: AUCtau of ENTO
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60, 72, 84, and 96 hours postdose on Day 5
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Pharmacokinetic (PK) Parameter: Cmax of ENTO
Time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60, 72, 84, and 96 hours postdose on Day 5
Cmax is defined as the maximum concentration of drug.
2 secondary outcomes
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 9 plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Time frame: Baseline up to Day 9 plus 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gilead Study Director study director
Gilead Sciences
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Entospletinib in people with Oncology, run by Gilead Sciences at 6 sites in 3 countries.
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 4 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 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany, New Zealand. 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 26 Jul 2019). 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?
Pharmacokinetic (PK) Parameter: AUCtau of ENTO (time frame: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60, 72, 84, and 96 hours postdose on Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2019.