Clinical trial NCT06174961: The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin
Official title: The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin: A Randomized, Controlled, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Coagulation Disorder
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Difference between interventions in change in incremental activated partial thromboplastin time (aPTT)
timeFrame: Peak aPTT for 1-8 hours after unfractionated heparin (UFH) injection
Secondary outcomes:
measure: Difference between interventions in change in incremental plasma heparin
timeFrame: Peak plasma heparin for 1-8 hours after UFH injection
measure: Difference between interventions in mean incremental aPTT
timeFrame: 1-8 hours after UFH injection
measure: Difference between interventions in mean incremental plasma heparin
timeFrame: 1-8 hours after UFH injection
measure: Difference between interventions in change in aPTT
timeFrame: 4 hours after UFH injection
measure: Difference between interventions in change in plasma heparin
timeFrame: 4 hours after UFH injection
measure: Difference between interventions in mean incremental natriuretic peptides
timeFrame: 1-8 hours after UFH injection
measure: Difference between interventions in mean incremental follistatin
timeFrame: 1-8 hours after UFH injection
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology
Study officials:
affiliation: Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology
name: Kristian Karstoft, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: