Blood Coagulation DisorderPhase 4NCT06174961
The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin
A Phase 4 study testing Unfractionated heparin, Double-legged cycle ergometer exercise and Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising leg in people with Blood Coagulation Disorder, run by Kristian Karstoft at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Coagulation Disorder
- What is being tested?
- Unfractionated heparin, Double-legged cycle ergometer exercise and Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising leg
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Sep 2023to 1 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology
Copenhagen, 2400
About this study
Official title: The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin: A Randomized, Controlled, Cross-over Study
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
- Being tested
- Unfractionated heparin, Double-legged cycle ergometer exercise, Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising leg, Single-legged cycle ergometer exercise, with unfractionated heparin injection in the non-exercising leg, No exercise
- Medical subject headings
- Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfractionated heparinDrug
15,000 units of unfractionated heparin administered in the thigh
Double-legged cycle ergometer exerciseBehavioural
One hour of double-leg cycle ergometer exercise
Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising legBehavioural
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 legBehavioural
One hour of single-leg cycle ergometer exercise, after unfractionated heparin injection in the ipsilateral leg
No exerciseBehavioural
No exercise
| Study group | Role | What they receive |
|---|---|---|
| Unfractionated heparin + No exercise | Experimental | 15,000 units of unfractionated heparin will be administered in the thigh. No exercise will be performed afterwards. Receives: Drug: Unfractionated heparin; Behavioral: No exercise |
| Unfractionated heparin + Double-legged cycle ergometer exercise | Experimental | 15,000 units of unfractionated heparin will be administered in the thigh. Double-legged cycle ergometer exercise will be performed for 1 hour afterwards Receives: Drug: Unfractionated heparin; Behavioral: Double-legged cycle ergometer exercise |
| Unfractionated heparin + Single-legged ipsilateral cycle ergometer exercise | Experimental | 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 Receives: 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 | 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 Receives: Drug: Unfractionated heparin; Behavioral: Single-legged cycle ergometer exercise, with unfractionated heparin injection in the non-exercising leg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between interventions in change in incremental activated partial thromboplastin time (aPTT)
Measured: Peak aPTT for 1-8 hours after unfractionated heparin (UFH) injection
Secondary outcomes (7)
Difference between interventions in change in incremental plasma heparin
Measured: Peak plasma heparin for 1-8 hours after UFH injection
Difference between interventions in mean incremental aPTT
Measured: 1-8 hours after UFH injection
Difference between interventions in mean incremental plasma heparin
Measured: 1-8 hours after UFH injection
Difference between interventions in change in aPTT
Measured: 4 hours after UFH injection
Difference between interventions in change in plasma heparin
Measured: 4 hours after UFH injection
Difference between interventions in mean incremental natriuretic peptides
Measured: 1-8 hours after UFH injection
Difference between interventions in mean incremental follistatin
Measured: 1-8 hours after UFH injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start22 Sep 2023
- Primary completion13 Feb 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristian Karstoft
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristian Karstoft, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Kristian Karstoft, MD, DMSc, Principal investigator, Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174961
- Sponsor's protocol ID
- 2023-000150-20
- Other IDs
- 2023
- Status last verified
- Jun 2024
- First submitted
- 8 Dec 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin: A Randomized, Controlled, Cross-over Study
- ClinicalTrials.gov ID
- NCT06174961
- Acronym / sponsor ID
- 2023-000150-20
- Conditions
- Blood Coagulation Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Kristian KarstoftUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Unfractionated heparin + No exercise | Experimental | Drug: Unfractionated heparin, Behavioral: No exercise15,000 units of unfractionated heparin will be administered in the thigh. No exercise will be performed afterwards. |
| Unfractionated heparin + Double-legged cycle ergometer exercise | Experimental | Drug: Unfractionated heparin, Behavioral: Double-legged cycle ergometer exercise15,000 units of unfractionated heparin will be administered in the thigh. Double-legged cycle ergometer exercise will be performed for 1 hour afterwards |
| Unfractionated heparin + Single-legged ipsilateral cycle ergometer exercise | Experimental | Drug: Unfractionated heparin, Behavioral: Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising leg15,000 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 |
| Unfractionated heparin + Single-legged contralateral cycle ergometer exercise | Experimental | Drug: Unfractionated heparin, Behavioral: Single-legged cycle ergometer exercise, with unfractionated heparin injection in the non-exercising leg15,000 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unfractionated heparin15,000 units of unfractionated heparin administered in the thigh | Drug | Unfractionated heparin + Double-legged cycle ergometer exercise, Unfractionated heparin + No exercise, Unfractionated heparin + Single-legged contralateral cycle ergometer exercise, Unfractionated heparin + Single-legged ipsilateral cycle ergometer exercise |
| Double-legged cycle ergometer exerciseOne hour of double-leg cycle ergometer exercise | Behavioural | Unfractionated heparin + Double-legged cycle ergometer exercise |
| Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising legOne hour of single-leg cycle ergometer exercise, after unfractionated heparin injection in the ipsilateral leg | Behavioural | Unfractionated heparin + Single-legged ipsilateral cycle ergometer exercise |
| Single-legged cycle ergometer exercise, with unfractionated heparin injection in the non-exercising legOne hour of single-leg cycle ergometer exercise, after unfractionated heparin injection in the ipsilateral leg | Behavioural | Unfractionated heparin + Single-legged contralateral cycle ergometer exercise |
| No exerciseNo exercise | Behavioural | Unfractionated heparin + No exercise |
Primary outcome
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
7 secondary outcomes
Difference between interventions in change in incremental plasma heparin
Time frame: Peak plasma heparin for 1-8 hours after UFH injection
Difference between interventions in mean incremental aPTT
Time frame: 1-8 hours after UFH injection
Difference between interventions in mean incremental plasma heparin
Time frame: 1-8 hours after UFH injection
Difference between interventions in change in aPTT
Time frame: 4 hours after UFH injection
Difference between interventions in change in plasma heparin
Time frame: 4 hours after UFH injection
Difference between interventions in mean incremental natriuretic peptides
Time frame: 1-8 hours after UFH injection
Difference between interventions in mean incremental follistatin
Time frame: 1-8 hours after UFH injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristian Karstoft, MD, DMSc principal investigator
Bispebjerg-Frederiksberg Hospital, Department of Clinical Pharmacology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Unfractionated heparin, Double-legged cycle ergometer exercise and Single-legged cycle ergometer exercise, with unfractionated heparin injection in the exercising leg in people with Blood Coagulation Disorder, run by Kristian Karstoft at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.