Clinical trial NCT06092788: Safety, Pharmacokinetics (PK) and Relative Bioavailability of NTP42:KVA4 as a Solid Oral Dose
Official title: Phase 1, Randomised, Open-label, 3-way Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics (With Food Effect), and Relative Bioavailability of NTP42:KVA4 Given as a Capsule, Compared With a Liquid, in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: ATXA Therapeutics Limited
Sponsor class: INDUSTRY
Collaborators: name: Hammersmith Medicines Research
First posted: 2023-10-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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-over study, the Trial will involve 3 dose sessions where all volunteers will receive 3 single doses of NTP42:KVA4. In two of the dose sessions, volunteers will be fasted where, in one, they will be given the NTP42:KVA4 capsule and, in another, they will be given NTP42:KVA4 in oral liquid form. To test the effect of food on drug absorption (PK), the volunteers will also be given the NTP42:KVA4 capsule after eating a full breakfast.


Eligibility 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.

Primary outcomes:
measure: Evaluate the safety and tolerability of NTP42:KVA4 when given as a capsule in healthy volunteers
timeFrame: Up to 48-hour post-dose
measure: Evaluation of the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers
timeFrame: Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing
measure: Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers
timeFrame: Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing
Secondary outcomes:
measure: Evaluation of the pharmacodynamics effects of NTP42:KVA4 when given as a capsule in healthy volunteers
timeFrame: Predose, 2-, 6-, 24- & 48-hours post-dosing
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
Study officials:
affiliation: Hammersmith Medicines Research
name: Takahiro Yamamoto, MD
role: PRINCIPAL_INVESTIGATOR
References: