A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-7117 in Healthy Subjects

NCT02834442 | Completed Phase 1

• 1 other identifier: MT-7117-E01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-7117 in healthy subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Safety and Tolerability as measured by number of participants with adverse events

  up to Day56

• Safety and Tolerability as measured by vital signs

  up to Day56

• Safety and Tolerability as measured by physical examination

  up to Day56

• Safety and Tolerability as measured by ECG

  up to Day21

• Safety and Tolerability as measured by laboratory safety assessments

  up to Day21

Secondary Outcomes (4)

• Maximum plasma concentration (Cmax)

  96 hours post dose

• Area under the plasma concentration-time curve (AUC)

  96 hours post dose

• Time to maximum plasma concentration (Tmax)

  96 hours post dose

• Apparent elimination half-life in plasma

  96 hours post dose

Study Arms (2)

Single ascending dose, MT-7117 or Placebo

EXPERIMENTAL

Drug: MT-7117; Drug: Placebo

Multiple ascending dose, MT-7117 or Placebo

EXPERIMENTAL

Drug: MT-7117; Drug: Placebo

Interventions

MT-7117 DRUG

Multiple ascending dose, MT-7117 or Placebo; Single ascending dose, MT-7117 or Placebo

Placebo DRUG

Multiple ascending dose, MT-7117 or Placebo; Single ascending dose, MT-7117 or Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy and free from clinically significant illness or disease
• Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
• A body weight of ≥60 kg for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2

You may not qualify if:

• Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks
• Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, renal, cardiovascular or skin disease, or history of any significant psychiatric/psychotic illness disorder
• Clinically relevant abnormal medical history, physical findings or laboratory values

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational center

United Kingdom, United Kingdom

Location

Related Publications (2)

• 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

• Ogasawara A, Ogawa K, Ide R, Ikenaga Y, Fukunaga C, Nakayama S, Tsuda M. Results from a first-in-human study of dersimelagon, an investigational oral selective MC1R agonist. Eur J Clin Pharmacol. 2023 Jun;79(6):801-813. doi: 10.1007/s00228-023-03476-6. Epub 2023 Apr 15.

  PMID: 37060458 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 15, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 25, 2017

Record last verified: 2017-07

Locations

GB (1)