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

Tanabe Pharma Corporation116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

116

Conditions

Healthy

Interventions

MT-4129DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pharmaceutical Research Associates (PRA) Health Sciences

City Name, Netherlands

Outcomes

Primary Outcomes

Safety and Tolerability as measured by incidence and severity of adverse events

Time frame: Up to Day 14

Safety and Tolerability as measured by vital signs

Time frame: Up to Day 14

Safety and Tolerability as measured by ECG

Time frame: Up to Day 14

Safety and Tolerability as measured by clinical laboratory assessments

Time frame: Up to Day 14

Safety and Tolerability as measured by Hormone assessments

Time frame: Up to Day 10

Safety and Tolerability as measured by physical examination

Time frame: Up to Day 14

Secondary Outcomes

Maximum observed plasma concentration (Cmax) of MT-4129

Time frame: Up to Day 10

Measured time of maximum observed plasma concentration (tmax) of MT-4129

Time frame: Up to Day 10

Apparent terminal elimination half-life (t1/2) of MT-4129

Time frame: Up to Day 10

AUC from time zero to 24 hours post-dose (AUC0-24) of MT-4129

Time frame: Up to Day 8

AUC from time zero to 48 hours post-dose (AUC0-48) of MT-4129

Time frame: Up to Day 9

Data from ClinicalTrials.gov

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