NCT02693197

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2016

Typical duration for phase_1 healthy

Geographic Reach
1 country

2 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

January 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 24, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

January 26, 2016

Last Update Submit

November 22, 2017

Conditions

HealthyHepatic Impairment

Keywords

Hepatic Impairment

Outcome Measures

Primary Outcomes (9)

  • Plasma concentrations

    8 days

  • Area under the plasma concentration time curve (AUC)

    8 days

  • Maximum observed plasma concentration (Cmax)

    8 days

  • Time to reach the maximum observed plasma concentration (tmax)

    8 days

  • Apparent terminal elimination rate constant

    8 days

  • Apparent terminal elimination half-life (t½)

    8 days

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

    8 days

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

    8 days

  • Metabolite to parent ratio (MPR)

    8 days

Secondary Outcomes (1)

  • Number of participants with treatment-related adverse events

    8days

Study Arms (6)

Cohort 1:T-817MA

EXPERIMENTAL

Mild hepatic impairment subjects

Drug: T-817MA

Cohort 2:T-817MA

EXPERIMENTAL

Healthy subjects matched to subjects in Cohort 1

Drug: T-817MA

Cohort 3:T-817MA

EXPERIMENTAL

Moderate hepatic impairment subjects

Drug: T-817MA

Cohort 4:T-817MA

EXPERIMENTAL

Healthy subjects matched to subjects in Cohort 3

Drug: T-817MA

Cohort 5 :T-817MA

EXPERIMENTAL

Severe hepatic impairment subjects

Drug: T-817MA

Cohort 6:T-817MA

EXPERIMENTAL

Healthy subjects matched to subjects in Cohort 5

Drug: T-817MA

Interventions

T-817MADRUG

A single oral dose of 448 mg

Cohort 1:T-817MACohort 2:T-817MACohort 3:T-817MACohort 4:T-817MACohort 5 :T-817MACohort 6:T-817MA

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami

Miami, Florida, United States

Location

Orlando Clinical Research Center

Orlando, Florida, United States

Location

MeSH Terms

Interventions

1-(3-(2-(1-benzothiophen-5-yl) ethoxy) propyl)-3-azetidinol maleate

Study Officials

  • Richard Preston, M.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Thomas Marbury, M.D.

    Orlando Clinical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 26, 2016

First Posted

February 26, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 24, 2017

Record last verified: 2017-05

Locations

US(2)