A Clinical Study to See How the Study Drug MT-4129 is Taken up by the Body in Healthy Volunteers

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: MT-4129

Study type: Interventional

Funder types: Industry

Identifiers

NCT02953132

MT-4129-E01

Details and patient eligibility

About

The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of MT-4129 in healthy subjects.

Enrollment: 116 estimated 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, neurological, 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

---

116 participants in 2 patient groups

Single ascending dose, MT-4129 or Placebo

Experimental group

Treatment:

Drug: Placebo

Drug: MT-4129

Multiple ascending dose, MT-4129 or Placebo

Experimental group

Treatment:

Drug: Placebo

Drug: MT-4129