Status:
COMPLETED
Safety, Pharmacokinetics (PK) and Relative Bioavailability of NTP42:KVA4 as a Solid Oral Dose
Lead Sponsor:
ATXA Therapeutics Limited
Collaborating Sponsors:
Hammersmith Medicines Research
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This Phase 1 clinical trial will assess the safety, tolerability and pharmacokinetics (PK) of a solid capsule form of NTP42:KVA4 in male and female healthy volunteers. In a randomised, 3-way cross-ove...
Eligibility Criteria
Inclusion
- A body mass index (BMI) in the range 18.0-30.0
- Ability \& willingness to provide written consent
Exclusion
- 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.
Key Trial Info
Start Date :
November 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT06092788
Start Date
November 24 2023
End Date
January 17 2024
Last Update
July 22 2024
Active Locations (1)
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1
Hammersmith Medicines Research
London, United Kingdom, NW10 7EW