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

Kristian Karstoft

Status and phase: Completed; Phase 4

Conditions: Blood Coagulation Disorder

Treatments: Behavioral: Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising leg; Behavioral: Double-legged cycle ergometer exercise; Drug: Unfractionated heparin; Behavioral: Single-legged cycle ergometer exercise, with unfractionated heparin injection in the non-exercising leg; Behavioral: No exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06174961

2023-000150-20

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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23 participants in 4 patient groups

Unfractionated heparin + No exercise

Experimental group

Description:

15,000 units of unfractionated heparin will be administered in the thigh. No exercise will be performed afterwards.

Treatment:

Behavioral: No exercise

Drug: Unfractionated heparin

Unfractionated heparin + Double-legged cycle ergometer exercise

Experimental group

Description:

15,000 units of unfractionated heparin will be administered in the thigh. Double-legged cycle ergometer exercise will be performed for 1 hour afterwards

Treatment:

Behavioral: Double-legged cycle ergometer exercise

Drug: Unfractionated heparin

Unfractionated heparin + Single-legged ipsilateral cycle ergometer exercise

Experimental group

Description:

15,000 units of unfractionated heparin will be administered in the thigh. Single-legged cycle ergometer exercise in leg where unfractionated heparin injection is given will be performed for 1 hour afterwards

Treatment:

Drug: Unfractionated heparin

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

Unfractionated heparin + Single-legged contralateral cycle ergometer exercise

Experimental group

Description:

15,000 units of unfractionated heparin will be administered in the thigh. Single-legged cycle ergometer exercise in contralateral leg to where unfractionated heparin injection is given will be performed for 1 hour afterwards

Treatment:

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

Drug: Unfractionated heparin