Healthy
Conditions
Keywords
Phase 1, Healthy subjects, Pharmacokinetics of MT-8554
Brief summary
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-8554 in healthy Caucasian subjects.
Interventions
DRUGMT-8554
DRUGPlacebo
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability as measured by laboratory safety assessments | up to Day14 |
| Safety and Tolerability as measured by ECG | up to Day14 |
| Safety and Tolerability as measured by continuous lead II ECG monitoring | up to Day14 |
| Safety and Tolerability as measured by vital signs | up to Day14 |
| Safety and Tolerability as measured by physical examination | up to Day14 |
| Safety and Tolerability as measured by number of participants with adverse events | up to Day14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK profile (Cmax, tmax, t½, AUC) | 240 hours post dose | Cmax, tmax, t½, AUC |
Countries
United Kingdom
Outcome results
None listed