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

NCT ID: NCT06092788

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-24
• Study Completion Date: 2024-01-17

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NTP42:KVA4 Capsule

Group Type: EXPERIMENTAL

NTP42:KVA4 Capsule

Intervention Type: DRUG

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

NTP42:KVA4 Oral Suspension

Group Type: ACTIVE_COMPARATOR

NTP42:KVA4 Liquid

Intervention Type: DRUG

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

Interventions

NTP42:KVA4 Capsule

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

Intervention Type: DRUG

NTP42:KVA4 Liquid

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hammersmith Medicines Research

OTHER

Sponsor Role: collaborator

ATXA Therapeutics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takahiro Yamamoto, MD

Role: PRINCIPAL_INVESTIGATOR

Hammersmith Medicines Research

Locations

Hammersmith Medicines Research

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

ATXA-CT002

Identifier Type: -

Identifier Source: org_study_id