Safety, Tolerability and Pharmacokinetics of NTP42:KVA4
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: NTP42:KVA4
|
Drug: NTP42:KVA4
Single ascending dose (SAD) or multiple ascending dose (MAD) of NTP42:KVA4 administered to healthy volunteers as an oral suspension.
|
Placebo Comparator: Placebo
|
Drug: Placebo
Placebo, matched to corresponding doses of NTP42:KVA4 administered to healthy volunteers as an oral solution.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hammersmith Medicines Research | London | United Kingdom | NW10 7EW |
Sponsors and Collaborators
- ATXA Therapeutics Limited
- Hammersmith Medicines Research
Investigators
- Principal Investigator: Malcolm Boyce, MD, Hammersmith Medicines Reserach
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ATXA-CT001