A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-8554 in Healthy Subjects

Tanabe Pharma Corporation

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: MT-8554

Study type: Interventional

Funder types: Industry

Identifiers

NCT02429102

MT-8554-E01

Details and patient eligibility

About

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-8554 in healthy Caucasian subjects.

Enrollment: 135 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 male and ≥50 kg female

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 2 patient groups

Single ascending dose, MT-8554 or Placebo

Experimental group

Treatment:

Drug: MT-8554

Drug: Placebo

Multiple ascending dose, MT-8554 or Placebo

Experimental group

Treatment:

Drug: MT-8554

Drug: Placebo