This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.
This is a single and multiple dose, parallel group study to assess safety and pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects. The study will be conducted in two parts: (A) single doses of HTL0018318 in healthy, adult, male Caucasian and Japanese subjects; (B) multiple doses of HTL0018318 in healthy, adult, male Caucasian and Japanese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
Part A single dose Part B five doses
Part B only
Richmond Pharmacology
London, London Bridge, United Kingdom
Cmax
Comparison of pharmacokinetics in plasma
Time frame: Baseline to 72 hours
Tmax
Comparison of pharmacokinetics in plasma
Time frame: Baseline to 72 hours
Area under the curve
Comparison of pharmacokinetics in plasma
Time frame: Baseline to 72 hours
Delay in absorption (Tlag)
Pharmacokinetics in plasma
Time frame: Baseline to 72 hours
Rate of elimination
Pharmacokinetics in plasma
Time frame: Baseline to 72 hours
Half life (t1/2)
Pharmacokinetics in plasma
Time frame: Baseline to 72 hours
Amount excreted in urine
Pharmacokinetics in urine
Time frame: Baseline to 72 hours
Fraction of dose eliminated unchanged in urine (fe/F)
Pharmacokinetics in urine
Time frame: Baseline to 72 hours
Treatment emergent adverse events (TEAEs)
Safety and tolerability
Time frame: Up to 14 day post dose
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Number of participants with abnormal physical exam results
Safety and tolerability
Time frame: Up to 14 day post dose
Heart Rate
Safety and tolerability
Time frame: Up to 14 day post dose
Number of participants with abnormal laboratory values
Safety and tolerability
Time frame: Up to 14 day post dose
ECG
Safety and tolerability
Time frame: Up to 14 day post dose
Blood pressure
Safety and tolerability
Time frame: Up to 14 day post dose