NCT04116476

Brief Summary

An Open-label, Single-center, Parallel-group Study to Assess Pharmacokinetics, Safety, and Tolerability of a Single Dose of MT-7117 in Subjects with Normal and Impaired Hepatic Function

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2021

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

1.5 years

First QC Date

October 3, 2019

Last Update Submit

May 12, 2023

Conditions

Mild and Moderate Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

  • Maximum observed plasma concentration (Cmax) of MT-7117

    0-96 Hours

  • Area under the plasma concentration time curve from time zero to the time of last quantifiable concentration (AUC0-last) of MT-7117

    0-96 Hours

  • Area under the plasma concentration time curve from time zero to infinity (AUC0-∞) of MT-7117

    0-96 Hours

Secondary Outcomes (6)

  • Time to reach maximum plasma concentration (tmax) of MT-7117

    0-96 Hours

  • Plasma terminal elimination half-life (t1/2) of MT-7117

    0-96 Hours

  • Apparent oral clearance (CL/F) of MT-7117

    0-96 Hours

  • Apparent volume of distribution (Vz/F) of MT-7117

    0-96 Hours

  • fraction of unbound drug in plasma or serum (fu) of MT-7117

    0-96 Hours

  • +1 more secondary outcomes

Study Arms (3)

Moderate Hepatic Impairment

EXPERIMENTAL
Drug: MT-7117

Normal Healthy Matches

EXPERIMENTAL
Drug: MT-7117

Mild Hepatic Impairment

EXPERIMENTAL
Drug: MT-7117

Interventions

MT-7117DRUG

Single Dose of MT-7117

Mild Hepatic ImpairmentModerate Hepatic ImpairmentNormal Healthy Matches

Eligibility Criteria

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

You may qualify if:

  • Male and female subjects 18 to 75 years of age inclusive
  • BMI 18 -35 kg/m2
  • If female, you are nonpregnant, non-lactating and willing to utilize approved methods of birth control.

You may not qualify if:

  • Subjects who have mild or moderate hepatic impairment according to Child-Pugh classification system at Screening (except normal healthy matches)
  • Subjects who have a known clinically significant (CS) hypersensitivity to MT-7117 or related compounds, including melatonin.
  • Subjects who have previously participated in a study involving MT-7117 or taken any other investigational drug within 30 days or 5 half-lives prior to the first dose of IMP, whichever is longer.
  • Subjects who have a CS or unstable neurological, renal, cardiovascular, gastrointestinal, pulmonary, or hematologic disease for 14 days prior to enrollment.
  • Subjects who have used any prescription or over-the-counter (OTC) medication within 14 days prior to first dose of IMP, except for occasional use of acetaminophen (\< 1 g/day for normal hepatic subjects, and \< 2 g/day for hepatically impaired subjects) or any other medication approved by the sponsor (a case-by-case basis). For hepatic impaired subjects, prescribed medication or OTC may be permitted by the Investigator and sponsor on a case-by-case basis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Clinical Pharmacology Unit

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • Ogasawara A, Ide R, Inoue S, Teng R, Kawaguchi A. Effect of Hepatic and Renal Impairment on the Pharmacokinetics of Dersimelagon (MT-7117), an Oral Melanocortin-1 Receptor Agonist. Clin Pharmacol Drug Dev. 2024 Jul;13(7):729-738. doi: 10.1002/cpdd.1413. Epub 2024 May 15.

    PMID: 38746989DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Head of Medical Science

    Tanabe Pharma America, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 4, 2019

Study Start

August 1, 2019

Primary Completion

February 16, 2021

Study Completion

February 16, 2021

Last Updated

May 15, 2023

Record last verified: 2023-05

Locations

US(1)