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NCT Number: NCT06174961

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

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.

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Key information

Conditions

Blood Coagulation Disorder Blood Coagulation Disorders Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body weight 50 kg or more
  • Body Mass Index 18.5-25 kg/m2
  • Acceptance of not drinking alcohol for 24 hours before to 24 hours after dosing of study drug
  • Acceptance of not performing physical activity for 24 hours before to 24 hours after dosing of study drug
  • Signed informed consent form

Exclusion criteria

  • History or sign of bleeding disorders
  • History or sign of kidney disease
  • History or sign of liver disease
  • Average systolic blood pressure <100 mmHg or >140 mmHg and/or average diastolic blood pressure <60 mmHg or >90 mmHg (average of three measurements performed at screening).
  • Daily pharmaceutical treatment
  • Contraindication to increased levels of physical activity (10)
  • Smoking or other regular use of any form of nicotine products during the study period and the previous 3 months.
  • Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator).
  • Previous treatment with heparins
  • Low levels of anti-thrombin (P-antitrombin(enz.) <0,80 kIU/L)

Treatment and study plan

Unfractionated heparin

Drug

15,000 units of unfractionated heparin administered in the thigh

Double-legged cycle ergometer exercise

Behavioral

One hour of double-leg cycle ergometer exercise

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

Behavioral

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

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

Behavioral

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

No exercise

Behavioral

No exercise

Primary outcomes

  1. Difference between interventions in change in incremental activated partial thromboplastin time (aPTT)

    Time frame: Peak aPTT for 1-8 hours after unfractionated heparin (UFH) injection

Secondary outcomes

  1. Difference between interventions in change in incremental plasma heparin

    Time frame: Peak plasma heparin for 1-8 hours after UFH injection

  2. Difference between interventions in mean incremental aPTT

    Time frame: 1-8 hours after UFH injection

  3. Difference between interventions in mean incremental plasma heparin

    Time frame: 1-8 hours after UFH injection

  4. Difference between interventions in change in aPTT

    Time frame: 4 hours after UFH injection

  5. Difference between interventions in change in plasma heparin

    Time frame: 4 hours after UFH injection

  6. Difference between interventions in mean incremental natriuretic peptides

    Time frame: 1-8 hours after UFH injection

  7. Difference between interventions in mean incremental follistatin

    Time frame: 1-8 hours after UFH injection

Sponsors and collaborators

Lead sponsor

Kristian Karstoft

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2023
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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