Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

NCT04919863 | Completed Phase 1

• 1 other identifier: ATXA-CT001
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

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

  Adverse events (AEs)

  Up to 48-hour post-dose.

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

  Pharmacokinetic parameter: Area under the Curve (AUC)

  Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing.

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

  Pharmacokinetic parameter: Area under the Curve (AUC)

  Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing.

Secondary Outcomes (1)

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

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

Study Arms (2)

NTP42:KVA4

EXPERIMENTAL

Drug: NTP42:KVA4

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NTP42:KVA4 DRUG

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

NTP42:KVA4

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A body mass index (BMI) in the range 18.0-30.0.
• Ability \& willingness to provide written consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ATXA Therapeutics Limited: lead
• Hammersmith Medicines Research: collaborator

Study Sites (1)

Hammersmith Medicines Research

London, NW10 7EW, United Kingdom

Location

Related Publications (1)

• Reid HM, Maginn M, Perkins CM, Mulvaney EP, Boyce M, Yamamoto T, Kinsella BT. Evaluation of NTP42, a novel thromboxane receptor antagonist, in a first-in-human phase I clinical trial. Front Pharmacol. 2023 Dec 21;14:1296188. doi: 10.3389/fphar.2023.1296188. eCollection 2023.

  PMID: 38178863 DERIVED

Study Officials

• Malcolm Boyce, MD

  Hammersmith Medicines Reserach

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 9, 2021
• Study Start: May 24, 2021
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

GB (1)