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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: MT-7117; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02834442

MT-7117-E01

Details and patient eligibility

About

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

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 2 patient groups

Single ascending dose, MT-7117 or Placebo

Experimental group

Treatment:

Drug: Placebo

Drug: MT-7117

Multiple ascending dose, MT-7117 or Placebo

Experimental group

Treatment:

Drug: Placebo

Drug: MT-7117