Safety, Pharmacokinetics (PK) and Relative Bioavailability of NTP42:KVA4 as a Solid Oral Dose

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06092788

Enrollment

Registered

2023-10-23

Start date

2023-11-24

Completion date

2024-01-17

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGNTP42:KVA4 Capsule

Single doses of NTP42:KVA4 administered to healthy volunteers as a capsule

DRUGNTP42:KVA4 Liquid

Single doses of NTP42:KVA4 administered to healthy volunteers as a liquid

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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 NTP42:KVA4 when given as a capsule in healthy volunteers	Up to 48-hour post-dose	Adverse events (AEs)
Evaluation of the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers	Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing	Pharmacokinetic parameter: Area under the curve (AUC)
Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers	Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing	Pharmacokinetic parameter: Area under the curve (AUC)

Secondary

Measure	Time frame	Description
Evaluation of the pharmacodynamics effects of NTP42:KVA4 when given as a capsule in healthy volunteers	Predose, 2-, 6-, 24- & 48-hours post-dosing	TXA2-induced platelet aggregometry

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026