MedTrace Logo

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

NCT06092788 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-07-22

No results posted yet for this study

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

Interventions

DRUG

NTP42:KVA4 Capsule

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

DRUG

NTP42:KVA4 Liquid

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

Sponsors & Collaborators

  • Hammersmith Medicines Research

    collaborator OTHER

  • ATXA Therapeutics Limited

    lead INDUSTRY

Principal Investigators

  • Takahiro Yamamoto, MD · Hammersmith Medicines Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-24
Primary Completion
2024-01-17
Completion
2024-01-17

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06092788 on ClinicalTrials.gov