Healthy
Conditions
Brief summary
A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of NTP42:KVA4 following oral administration in a randomized, double-blind, placebo-controlled trial. The trial will involve of 2 phases, a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD phase will incorporate a food effect arm.
Interventions
DRUGNTP42:KVA4
Single ascending dose (SAD) or multiple ascending dose (MAD) of NTP42:KVA4 administered to healthy volunteers as an oral suspension.
DRUGPlacebo
Placebo, matched to corresponding doses of NTP42:KVA4 administered to healthy volunteers as an oral solution.
Sponsors
Hammersmith Medicines Research
ATXA Therapeutics Limited
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* A body mass index (BMI) in the range 18.0-30.0. * Ability & willingness to provide written consent.
Exclusion criteria
* Clinically relevant abnormal medical history, physical findings, laboratory values at pre-trial screening. * History of bleeding disorders, coagulation variables or abnormal blood cell count. * History of chronic illness. * Impaired endocrine, thyroid, hepatic, renal or respiratory function, diabetes mellitus, coronary heart disease or history of any psychotic mental illness. * History of adverse reaction or allergy to any drug. * Use of aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any other medicine that affects platelet function or coagulation, or any prescription medicine, during the 28 days before the first dose of trial medication. * History of drug or alcohol abuse * Smoker or use of nicotine-containing products * Blood pressure or heart rate at screening outside normal ranges.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety and tolerability of single and repeated doses of NTP42:KVA4 in healthy volunteers. | Up to 48-hour post-dose. | Adverse events (AEs) |
| Evaluation of the pharmacokinetics of single and repeated doses of NTP42:KVA4 in healthy volunteers. | Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing. | Pharmacokinetic parameter: Area under the Curve (AUC) |
| Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 in healthy volunteers. | Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing. | Pharmacokinetic parameter: Area under the Curve (AUC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the pharmacodynamics effects of NTP42:KVA4 in healthy volunteers. | Predose, 0.75, 2, 4, 8, 12 & 24 hours post-dosing | TXA2-induced platelet aggregometry |
Countries
United Kingdom
Outcome results
None listed