Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

Sponsor
ATXA Therapeutics Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT04919863
Collaborator
Hammersmith Medicines Research (Other)
79
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2
7.9
10

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

Study Type:
Interventional
Actual Enrollment :
79 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of NTP42:KVA4 in Healthy Volunteers
Actual Study Start Date :
May 24, 2021
Actual Primary Completion Date :
Jan 20, 2022
Actual Study Completion Date :
Jan 20, 2022

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

  1. 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)

  2. 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)

  3. 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

  1. 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

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts 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.

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.
Responsible Party:
ATXA Therapeutics Limited
ClinicalTrials.gov Identifier:
NCT04919863
Other Study ID Numbers:
  • ATXA-CT001
First Posted:
Jun 9, 2021
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 24, 2022