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The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin

NCT06174961 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-06-26

No results posted yet for this study

Summary

The aim of this project is to assess the influence of exercise on pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of subcutaneously (sc) administered unfractionated heparin (UFH). It is hypothesized that exercise will increase the systemic exposure (PK) and therefore the clinical effects (PD) of the sc administered UFH.

To assess this, healthy male volunteers will be included in a controlled, randomized, crossover study, where they, on four separate days, will have UFH injected sc in the thigh, followed by different exercise interventions (one per experimental day). Blood sampling, with the aim of assessing PK and PD will be performed during the following hours.

Conditions

  • Blood Coagulation Disorder

Interventions

DRUG

Unfractionated heparin

15,000 units of unfractionated heparin administered in the thigh

BEHAVIORAL

Double-legged cycle ergometer exercise

One hour of double-leg cycle ergometer exercise

BEHAVIORAL

Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising leg

One hour of single-leg cycle ergometer exercise, after unfractionated heparin injection in the ipsilateral leg

BEHAVIORAL

Single-legged cycle ergometer exercise, with unfractionated heparin injection in the non-exercising leg

One hour of single-leg cycle ergometer exercise, after unfractionated heparin injection in the ipsilateral leg

BEHAVIORAL

No exercise

No exercise

Sponsors & Collaborators

  • Kristian Karstoft

    lead OTHER

Principal Investigators

  • Kristian Karstoft, MD, DMSc · Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2024-02-13
Completion
2024-05-01

Countries

  • Denmark

Study Locations

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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 NCT06174961 on ClinicalTrials.gov