NCT06174961

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

The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin: A Randomized, Controlled, Cross-over Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Kristian Karstoft · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-09-22
• Primary completion: 2024-02-13
• Completion: 2024-05-01
• First posted: 2023-12-18
• Last updated: 2024-06-26

Locations

1 site across 1 country: Denmark