Study to Investigate Drug-Drug Interaction Between MT-7117 and Test Drugs in Healthy Subjects

NCT04793295 | Completed Phase 1 FDA Drug

• 1 other identifier: MT-7117-Z-102
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

Brief Summary

Study is to investigate drug levels in the blood after taking single or multiple doses of the study drug, MT-7117, in healthy adults when taken together with another drug. This study will also look at the safety and the body's ability to tolerate MT-7117

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  PK parameters of IMP Test Products in the absence and presence of MT-7117 (Parts 1, 2, and 3) and MT-7117 in the absence and presence of test drug 7 (Part 4)

  Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13

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

  PK parameters of IMP Test Products in the absence and presence of MT-7117 (Parts 1, 2, and 3) and MT-7117 in the absence and presence of test drug 7 (Part 4)

  Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13

• AUC from time zero to the last measurable concentration (AUC0-last)

  PK parameters of IMP Test Products in the absence and presence of MT-7117 (Parts 1, 2, and 3) and MT-7117 in the absence and presence of test drug 7 (Part 4)

  Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13

Secondary Outcomes (11)

• Time to reach maximum plasma concentration (tmax)

  Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13

• t1/2

  Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13

• Apparent oral clearance

  Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13

• Apparent volume of distribution during the terminal phase after oral administration

  Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13

• Cmax

  Part 1 Day 1 to Day 19, Part 2 Day 1 to Day 15, Part 3 Day 1 to Day 17, Part 4 Day 1 to Day 13

Study Arms (4)

MT-7117 Drug-drug interaction with test drug 1 and test drug 2

EXPERIMENTAL

Drug: MT-7117

MT-7117 Drug-drug interaction with test drug 3 and test drug 4

EXPERIMENTAL

Drug: MT-7117

MT-7117 Drug-drug interaction with test drug 5 and test drug 6

EXPERIMENTAL

Drug: MT-7117

MT-7117 Drug-drug interaction with test drug 7

EXPERIMENTAL

Drug: MT-7117

Interventions

MT-7117 DRUG

MT-7117

Also known as: Dersimelagon

MT-7117 Drug-drug interaction with test drug 1 and test drug 2; MT-7117 Drug-drug interaction with test drug 3 and test drug 4; MT-7117 Drug-drug interaction with test drug 5 and test drug 6; MT-7117 Drug-drug interaction with test drug 7

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able and willing to provide written informed consent to participate in this study after reading the participant information sheet and Informed Consent Form (ICF) and having the opportunity to discuss the study with the Investigator or designee.
• Male and female subjects, self-reporting as white, 18-55 years of age, inclusive, at the time of signing the ICF.
• Subjects must weigh at least 50 kg (110 pounds) and have a body mass index 18-30 kg/m2, inclusive, at Screening and on Day -1.
• Female subjects must not be lactating, and women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to receiving the first dose of IMP or IMP Test Products.
• Female subjects of childbearing potential and male subjects with a partner of childbearing potential must agree to use 2 effective methods of contraception (in female subjects, one method must be highly effective). Full details of contraception in Section 4.6.5.
• In the Investigator's opinion, the subject must be able to understand the nature of the study and any risks involved in participation and be willing to cooperate and comply with the protocol restrictions and requirements.

You may not qualify if:

• Presence or history of any hepatobiliary disease at Screening, determined clinically significant by the Investigator after discussion with the Sponsor's Responsible Physician. Current, or history of, clinically significant (in the opinion of the Investigator AND Sponsor's Responsible Physician) neurological conditions, endocrine, thyroid, respiratory, gastrointestinal, renal, or cardiovascular disease, or history (within the last 2 years) of any clinically significant psychiatric/psychotic illness disorder (including anxiety, depression, and reactive depression).
• Clinically relevant abnormal medical history, physical findings, or laboratory values at Screening or Day-1 that could interfere with the objectives of the study or the safety of the subjects, in the opinion of the Investigator.
• Family history of long or short QT syndrome, hypokalemia, syncope, or Torsades de Pointes.
• Clinically significant 12-lead electrocardiogram (ECG) abnormalities, including subjects with corrected QC interval (QTc) using Fridericia's formula \>450 ms (male) and \>470 ms (female), at Screening or Day -1. A repeat assessment is allowed at each visit. If the repeat measurement is in range, the subject may be included.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 1.5 the upper limit of normal (ULN) reference range, or bilirubin ≥ 1.5 ULN at screening or Day-1. A repeat assessment is allowed at each visit. If the repeat measurement is in range, the subject may be included.
• Systolic blood pressure outside the range of 90-145 mmHg, diastolic blood pressure outside the range of 50-95 mmHg, or pulse rate outside the range of 50-100 bpm, taken in the supine position at Screening or Day -1. A repeat assessment is allowed at each visit. If the repeat measurement is in range, the subject may be included.
• Receipt of any prescribed of nonprescribed systemic or topical medication within 30 days (or, if relevant, 5 half-lives, whichever is longer) prior to the first dose of study drugs unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise subject safety.
• Occasional use of paracetamol (acetaminophen) for mild analgesia is permitted.
• Vitamins and herbal supplements are not permitted 14 days prior to dosing
• Presence or history of severe adverse reaction or allergy to food or any drug or excipient or other allergy that is of clinical significance to the study drugs.
• Previous receipt of MT-7117.
• First-degree relative with a history of familial melanoma.
• Previous use of afamelanotide or melanotan.
• Female subjects planning to donate eggs (during the study and for 3 months after the last visit).
• Positive test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV) 1 or HIV 2 antibodies at Screening.

Sponsors & Collaborators

• Tanabe Pharma America, Inc.: lead

Study Sites (2)

Advanced Pharma CR, LLC

Miami, Florida, 33147, United States

Location

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

Related Publications (1)

• Ogasawara A, Ide R, Inoue S, Tsuda M, Teng R. Assessment of Potential Drug-Drug Interactions for Novel Oral Melanocortin-1 Receptor Agonist Dersimelagon. Pharmacol Res Perspect. 2025 Feb;13(1):e70069. doi: 10.1002/prp2.70069.

  PMID: 39887900 DERIVED

Study Officials

• Head of Medical Science

  Tanabe Pharma America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 11, 2021
• Study Start: March 23, 2021
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)