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Completed

NCT Number: NCT02693197

PK Study of T-817 in Subjects With Hepatic Impairment

The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment compared to matched healthy control subjects.

The secondary objective is to determine the safety and tolerability of single-dose T -817MA (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.

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Key information

Conditions

Healthy Hepatic Impairment

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Miami, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

For subjects with mild, moderate or severe hepatic impairment

  • Adult male or female, 18 - 75 years of age
  • Must weigh at least 50 kg and have a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m2
  • Have mild, moderate or severe defined by Child-Pugh classification hepatic impairment

For Matched Healthy Control Subjects Healthy adult male or female subjects will be matched 1:1 to a specific subject in the mild, moderate, or severe hepatic impairment cohort based upon age, weight, gender, and smoking status

Exclusion criteria

  • Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
  • History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
  • History or presence of hypersensitivity or idiosyncratic reaction to the study drug, related compounds, or inactive ingredients.
  • Female subjects who are pregnant or lactating.

Treatment and study plan

T-817MA

Drug

A single oral dose of 448 mg

Primary outcomes

  1. Plasma concentrations

    Time frame: 8 days

  2. Area under the plasma concentration time curve (AUC)

    Time frame: 8 days

  3. Maximum observed plasma concentration (Cmax)

    Time frame: 8 days

  4. Time to reach the maximum observed plasma concentration (tmax)

    Time frame: 8 days

  5. Apparent terminal elimination rate constant

    Time frame: 8 days

  6. Apparent terminal elimination half-life (t½)

    Time frame: 8 days

  7. Apparent total plasma clearance of unbound drug after oral (extravascular) administration (CL/F)

    Time frame: 8 days

  8. Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vd/F)

    Time frame: 8 days

  9. Metabolite to parent ratio (MPR)

    Time frame: 8 days

Secondary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: 8days

Sponsors and collaborators

Lead sponsor

FUJIFILM Toyama Chemical Co., Ltd.

Industry

Collaborators

  • Celerion

Registry information

Official study title

A Phase 1, Two-Part, Open-Label, Parallel-Cohort, Single-Dose Study to Determine the Pharmacokinetics of T-817MA in Adult Subjects With Hepatic Impairment and in Healthy Adult Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2016
Registry last updated
Nov 24, 2017

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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