NCT02521376

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2015

Typical duration for phase_1

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

November 16, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

July 26, 2019

Completed
Last Updated

July 26, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

August 10, 2015

Results QC Date

May 24, 2019

Last Update Submit

May 24, 2019

Conditions

Oncology

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    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)

    Baseline up to Day 9 plus 30 days

  • Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

    Baseline up to Day 9 plus 30 days

Study Arms (3)

Cohort 1 (Moderate Hepatic Impairment)

EXPERIMENTAL

Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.

Drug: Entospletinib

Cohort 2 (Severe Hepatic Impairment)

EXPERIMENTAL

Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.

Drug: Entospletinib

Cohort 3 (Mild Hepatic Impairment)

EXPERIMENTAL

Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.

Drug: Entospletinib

Interventions

EntospletinibDRUG

Entospletinib 100 mg tablet administered orally

Also known as: GS-9973
Cohort 1 (Moderate Hepatic Impairment)Cohort 2 (Severe Hepatic Impairment)Cohort 3 (Mild Hepatic Impairment)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Participation in another clinical study (current or within last 30 days)
  • HIV, hepatitis B virus, or active hepatitis C virus infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Clinical Pharmacology of Miami, Inc. (CPMI)

Miami, Florida, United States

Location

Orlando Clinical Research Center

Orlando, Florida, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, United States

Location

The Texas Liver Institute

San Antonio, Texas, United States

Location

APEX GmBH

Munich, Germany

Location

Auckland Clinical Studies

Auckland, New Zealand

Location

MeSH Terms

Conditions

Neoplasms

Interventions

6-(1H-indazol-6-yl)-N-(4-morpholinophenyl)imidazo(1,2-a)pyrazin-8-amine

Results Point of Contact

Title
Gilead Clinical Study Information Center
Organization
Gilead Sciences
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 13, 2015

Study Start

November 16, 2015

Primary Completion

October 25, 2017

Study Completion

October 25, 2017

Last Updated

July 26, 2019

Results First Posted

July 26, 2019

Record last verified: 2019-05

Locations

US(4)DE(1)NZ(1)