Back to resultsSafety, Pharmacokinetics (PK) and Relative Bioavailability of NTP42:KVA4 as a Solid Oral Dose
Primary Purpose
Healthy
Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
NTP42:KVA4 Capsule
NTP42:KVA4 Liquid
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
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.
Sites / Locations
- Hammersmith Medicines ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NTP42:KVA4 Capsule
NTP42:KVA4 Oral Suspension
Arm Description
Outcomes
Primary Outcome Measures
Evaluate the safety and tolerability of NTP42:KVA4 when given as a capsule in healthy volunteers
Adverse events (AEs)
Evaluation of the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers
Pharmacokinetic parameter: Area under the curve (AUC)
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)
Secondary Outcome Measures
Evaluation of the pharmacodynamics effects of NTP42:KVA4 when given as a capsule in healthy volunteers
TXA2-induced platelet aggregometry
Full Information
NCT ID
NCT06092788
First Posted
October 16, 2023
Last Updated
October 20, 2023
Sponsor
ATXA Therapeutics Limited
Collaborators
Hammersmith Medicines Research
1. Study Identification
Unique Protocol Identification Number
NCT06092788
Brief Title
Safety, Pharmacokinetics (PK) and Relative Bioavailability of NTP42:KVA4 as a Solid Oral Dose
Official Title
Phase 1, Randomised, Open-label, 3-way Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics (With Food Effect), and Relative Bioavailability of NTP42:KVA4 Given as a Capsule, Compared With a Liquid, in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ATXA Therapeutics Limited
Collaborators
Hammersmith Medicines Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NTP42:KVA4 Capsule
Arm Type
Experimental
Arm Title
NTP42:KVA4 Oral Suspension
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
NTP42:KVA4 Capsule
Intervention Description
Single doses of NTP42:KVA4 administered to healthy volunteers as a capsule
Intervention Type
Drug
Intervention Name(s)
NTP42:KVA4 Liquid
Intervention Description
Single doses of NTP42:KVA4 administered to healthy volunteers as a liquid
Primary Outcome Measure Information:
Title
Evaluate the safety and tolerability of NTP42:KVA4 when given as a capsule in healthy volunteers
Description
Adverse events (AEs)
Time Frame
Up to 48-hour post-dose
Title
Evaluation of the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers
Description
Pharmacokinetic parameter: Area under the curve (AUC)
Time Frame
Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing
Title
Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 when given as a capsule in healthy volunteers
Description
Pharmacokinetic parameter: Area under the curve (AUC)
Time Frame
Predose, 0.75-, 2-, 4, 6-, 8-, 12-, 24- & 48-hours post-dosing
Secondary Outcome Measure Information:
Title
Evaluation of the pharmacodynamics effects of NTP42:KVA4 when given as a capsule in healthy volunteers
Description
TXA2-induced platelet aggregometry
Time Frame
Predose, 2-, 6-, 24- & 48-hours post-dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Switchboard
Phone
+44(0) 20 8961 4130
Email
HMR@hmrlondon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takahiro Yamamoto, MD
Organizational Affiliation
Hammersmith Medicines Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammersmith Medicines Research
City
London
ZIP/Postal Code
NW10 7EW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Switchboard
Phone
+44 (0) 20 8961 4130
Email
HMR@hmrlondon.com
First Name & Middle Initial & Last Name & Degree
Takahiro Yamamoto, MD
12. IPD Sharing Statement
Learn more about this trial
Safety, Pharmacokinetics (PK) and Relative Bioavailability of NTP42:KVA4 as a Solid Oral Dose
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