Safety, Tolerability and Pharmacokinetics of NTP42:KVA4

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04919863
• Other study ID #: ATXA-CT001
• Status: Completed
• Phase: Phase 1
• Start date: May 24, 2021
• Est. completion date: January 20, 2022

Study information

• Verified date: February 2022
• Source: ATXA Therapeutics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• NTP42:KVA4
Single ascending dose (SAD) or multiple ascending dose (MAD) of NTP42:KVA4 administered to healthy volunteers as an oral suspension.
• Placebo
Placebo, matched to corresponding doses of NTP42:KVA4 administered to healthy volunteers as an oral solution.

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (2)

Lead Sponsor	Collaborator
ATXA Therapeutics Limited	Hammersmith Medicines Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Evaluation of the pharmacodynamics effects of NTP42:KVA4 in healthy volunteers.	TXA2-induced platelet aggregometry	Predose, 0.75, 2, 4, 8, 12 & 24 hours post-dosing