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Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04919863
Recruitment Status : Completed
First Posted : June 9, 2021
Last Update Posted : February 24, 2022
Sponsor:
Collaborator:
Hammersmith Medicines Research
Information provided by (Responsible Party):
ATXA Therapeutics Limited

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
Healthy Drug: NTP42:KVA4 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : January 20, 2022
Actual Study Completion Date : January 20, 2022

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04919863


Locations
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United Kingdom
Hammersmith Medicines Research
London, United Kingdom, NW10 7EW
Sponsors and Collaborators
ATXA Therapeutics Limited
Hammersmith Medicines Research
Investigators
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Principal Investigator: Malcolm Boyce, MD Hammersmith Medicines Reserach
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Responsible Party: ATXA Therapeutics Limited
ClinicalTrials.gov Identifier: NCT04919863    
Other Study ID Numbers: ATXA-CT001
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No