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

Blood Coagulation Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06174961
• Other study ID #: 2023-000150-20
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 22, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: February 2024
• Source: University Hospital Bispebjerg and Frederiksberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: January 31, 2025
• Est. primary completion date: February 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Blood Coagulation Disorder
• Blood Coagulation Disorders
• Hemostatic Disorders

Intervention

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
• 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
• 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
• No exercise
No exercise

Locations

Country	Name	City	State
Denmark	Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Kristian Karstoft

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between interventions in change in incremental activated partial thromboplastin time (aPTT)		Peak aPTT for 1-8 hours after unfractionated heparin (UFH) injection
Secondary	Difference between interventions in change in incremental plasma heparin		Peak plasma heparin for 1-8 hours after UFH injection
Secondary	Difference between interventions in mean incremental aPTT		1-8 hours after UFH injection
Secondary	Difference between interventions in mean incremental plasma heparin		1-8 hours after UFH injection
Secondary	Difference between interventions in change in aPTT		4 hours after UFH injection
Secondary	Difference between interventions in change in plasma heparin		4 hours after UFH injection
Secondary	Difference between interventions in mean incremental natriuretic peptides		1-8 hours after UFH injection
Secondary	Difference between interventions in mean incremental follistatin		1-8 hours after UFH injection