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Completed

NCT Number: NCT02521376

Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver 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.

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Key information

Conditions

Oncology Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

APEX GmBH, Munich, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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:

  • 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.

Treatment and study plan

Entospletinib

Drug

Entospletinib 100 mg tablet administered orally

Other names: GS-9973

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Baseline up to Day 9 plus 30 days

    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.

  2. Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

    Time frame: Baseline up to Day 9 plus 30 days

    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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics of Entospletinib in Subjects With Normal and Impaired Hepatic Function

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 13, 2015
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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