Phase 1, first in human, two-part, single centre, placebo-controlled, single and multiple ascending dose trial in healthy younger and elderly adult subjects, with an open-label, randomised, crossover arms to assess the effect of food on bioavailability.
This is a first in human single and multiple ascending dose study with the objective to evaluate safety, tolerability, PK, PD, and food effect of HTL0016878 in healthy younger and elderly subjects. Part 1 will assess single doses of HTL0016878 and Part 2 will assess multiple doses of HTL0016878. Part 1 will be divided into 3 sub-parts: Part 1a will assess single ascending doses (SAD) of HTL0016878 in younger adult subjects, Part 1b will evaluate the effect of food on bioavailability of HTL0016878 and part 1c will investigate the effect of age on the PK of HTL0016878. Part 1c will only proceed after review of safety, tolerability and PK data from part 1a. Part 2 will be divided into 2 sub-parts to assess multiple ascending doses (MAD) of HTL0016878 in younger adult (part 2a) and elderly adult (part 2b) subjects. Part 2 will only proceed after review of safety, tolerability and PK data from Parts 1a, b and c.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Oral solution
Matching placebo
Hammersmith Medicines Research
London, Hammersmith, United Kingdom
Treatment emergent adverse events (TEAEs)
Safety and Tolerability
Time frame: Baseline up to 14 days post dose
Physical examinations
Safety and Tolerability
Time frame: Baseline up to 14 days post dose
vital signs (Heart Rate and Blood pressure)
Safety and Tolerability
Time frame: Baseline up to 14 days post dose
Laboratory safety assessment
Safety and Tolerability
Time frame: Baseline up to 14 days post dose
ECG
Safety and Tolerability
Time frame: Baseline up to 14 days post dose
Columbia- suicide severity rating scale (C-SSRS)
Safety and Tolerability
Time frame: Baseline up to 14 days post dose
Maximum plasma concentration (Cmax) of HTL0016878
Pharmacokinetics
Time frame: Baseline up to 14 days post dose
Time to Maximum plasma concentration (Tmax) of HTL0016878
Pharmacokinetics
Time frame: Baseline up to 14 days post dose
Area under the curve of HTL0016878
Pharmacokinetics
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Time frame: Baseline up to 14 days post dose
Half-life (t1/2) of HTL0016878
Pharmacokinetics
Time frame: Baseline up to 14 days post dose
Amount excreted in urine (Ae) of HTL0016878
Pharmacokinetics
Time frame: Baseline up to 14 days post dose
Fraction of dose eliminated unchanged on urine (fe/F) of HTL0016878
Pharmacokinetics
Time frame: Baseline up to 14 days post dose