Healthy
Conditions
Brief summary
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-7117 in healthy subjects.
Interventions
DRUGMT-7117
DRUGPlacebo
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability as measured by laboratory safety assessments | up to Day21 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Maximum plasma concentration (Cmax) | 96 hours post dose |
Countries
United Kingdom
Outcome results
None listed