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

NCT ID: NCT06174961

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-22
• Study Completion Date: 2024-05-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unfractionated heparin + No exercise

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

Group Type: EXPERIMENTAL

Unfractionated heparin

Intervention Type: DRUG

15,000 units of unfractionated heparin administered in the thigh

No exercise

Intervention Type: BEHAVIORAL

No exercise

Unfractionated heparin + Double-legged cycle ergometer exercise

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

Group Type: EXPERIMENTAL

Unfractionated heparin

Intervention Type: DRUG

15,000 units of unfractionated heparin administered in the thigh

Double-legged cycle ergometer exercise

Intervention Type: BEHAVIORAL

One hour of double-leg cycle ergometer exercise

Unfractionated heparin + Single-legged ipsilateral cycle ergometer exercise

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

Group Type: EXPERIMENTAL

Unfractionated heparin

Intervention Type: DRUG

15,000 units of unfractionated heparin administered in the thigh

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

Intervention Type: BEHAVIORAL

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

Unfractionated heparin + Single-legged contralateral cycle ergometer exercise

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

Group Type: EXPERIMENTAL

Unfractionated heparin

Intervention Type: DRUG

15,000 units of unfractionated heparin administered in the thigh

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

Intervention Type: BEHAVIORAL

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

Interventions

Unfractionated heparin

15,000 units of unfractionated heparin administered in the thigh

Intervention Type: DRUG

Double-legged cycle ergometer exercise

One hour of double-leg cycle ergometer exercise

Intervention Type: 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

Intervention Type: 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

Intervention Type: BEHAVIORAL

No exercise

No exercise

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kristian Karstoft

OTHER

Sponsor Role: lead

Responsible Party

Kristian Karstoft

Chief Physician, Principal Investigator, MD, PhD, DMSc

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kristian Karstoft, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology

Locations

Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

2023-000150-20

Identifier Type: -

Identifier Source: org_study_id