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Completed

NCT Number: NCT04919863

Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NTP42:KVA4

Drug

Single ascending dose (SAD) or multiple ascending dose (MAD) of NTP42:KVA4 administered to healthy volunteers as an oral suspension.

Placebo

Drug

Placebo, matched to corresponding doses of NTP42:KVA4 administered to healthy volunteers as an oral solution.

Primary outcomes

  1. Evaluate the safety and tolerability of single and repeated doses of NTP42:KVA4 in healthy volunteers.

    Time frame: Up to 48-hour post-dose.

    Adverse events (AEs)

  2. Evaluation of the pharmacokinetics of single and repeated doses of NTP42:KVA4 in healthy volunteers.

    Time frame: 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)

  3. Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 in healthy volunteers.

    Time frame: 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 outcomes

  1. Evaluation of the pharmacodynamics effects of NTP42:KVA4 in healthy volunteers.

    Time frame: Predose, 0.75, 2, 4, 8, 12 & 24 hours post-dosing

    TXA2-induced platelet aggregometry

Sponsors and collaborators

Lead sponsor

ATXA Therapeutics Limited

Industry

Collaborators

  • Hammersmith Medicines Research

Registry information

Official study title

A Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of NTP42:KVA4 in Healthy Volunteers

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2021
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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