Safety, Pharmacokinetics (PK) and Relative Bioavailability of NTP42:KVA4 as a Solid Oral Dose

NCT06092788 | Completed Phase 1

• 1 other identifier: ATXA-CT002
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase 1 clinical trial will assess the safety, tolerability and pharmacokinetics (PK) of a solid capsule form of NTP42:KVA4 in male and female healthy volunteers. In a randomised, 3-way cross-over study, the Trial will involve 3 dose sessions where all volunteers will receive 3 single doses of NTP42:KVA4. In two of the dose sessions, volunteers will be fasted where, in one, they will be given the NTP42:KVA4 capsule and, in another, they will be given NTP42:KVA4 in oral liquid form. To test the effect of food on drug absorption (PK), the volunteers will also be given the NTP42:KVA4 capsule after eating a full breakfast.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Evaluate the safety and tolerability of NTP42:KVA4 when given as a capsule in healthy volunteers

  Adverse events (AEs)

  Up to 48-hour post-dose

• Evaluation of the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers

  Pharmacokinetic parameter: Area under the curve (AUC)

  Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing

• Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers

  Pharmacokinetic parameter: Area under the curve (AUC)

  Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing

Secondary Outcomes (1)

• Evaluation of the pharmacodynamics effects of NTP42:KVA4 when given as a capsule in healthy volunteers

  Predose, 2-, 6-, 24- & 48-hours post-dosing

Study Arms (2)

NTP42:KVA4 Capsule

EXPERIMENTAL

Drug: NTP42:KVA4 Capsule

NTP42:KVA4 Oral Suspension

ACTIVE COMPARATOR

Drug: NTP42:KVA4 Liquid

Interventions

NTP42:KVA4 Capsule DRUG

Single doses of NTP42:KVA4 administered to healthy volunteers as a capsule

NTP42:KVA4 Capsule

NTP42:KVA4 Liquid DRUG

Single doses of NTP42:KVA4 administered to healthy volunteers as a liquid

NTP42:KVA4 Oral Suspension

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• 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

Study Officials

• Takahiro Yamamoto, MD

  Hammersmith Medicines Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: November 24, 2023
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

GB (1)