Congenital Bleeding DisorderPhase 1NCT01555749
Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese Subjects
A Phase 1 study testing NNC172-2021 in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 1 site in United Kingdom.
Trial summary
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (how the trial drug is distributed in the body) of NNC172-2021 administered subcutaneously, at two different dose levels, in healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
- What is being tested?
- NNC172-2021
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Mar 2012to 8 May 2012
- Phase
- Phase 1
- 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 20 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male Japanese subjects defined as: Subjects born in Japan, time residing outside of Japan does not exceed 5 years, both parents and all 4 grandparents of Japanese descent
- Body weight between 50 and 100 kg, both inclusive
- Body mass index (BMI) between 18.0 and 30.0 kg/m^2, both inclusive
Who cannot join
- Male subjects who are sexually active and not surgically sterilised who, or whose partner, are unwilling to use two different forms of effective contraception, one of which has to be a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 3 months following the last dose of trial medication
- Planned surgery 30 days prior to trial product administration and/or during the entire trial period
- Known hepatic dysfunction during the last 12 months prior to screening (Visit 1)
- Positive urine test for drugs of abuse
- Active hepatitis B and/or hepatitis C infection
- Positive for human immunodeficiency virus (HIV)
Show all 13Show fewer
- Subjects with clinical signs of thromboembolic events, considered to be at high risk of thromboembolic event or subjects with a known first degree family history of thromboembolism
- Participation in any other trial investigating other products or involving blood sampling within the last 30 days prior to screening
- Use of non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (ASA), but not ibuprofen and cyclooxygenase-2 (COX-2) specific inhibitors within 2 weeks prior to trial product administration (Visit 2)
- Positive alcohol test at screening (Visit 1) and/or history of alcohol or drug abuse within the last 12 months prior to screening (Visit 1)
- Smokers; defined as tobacco users smoking more than 5 cigarettes per day or the corresponding amount of tobacco consumption
- Blood donation within the last 3 months prior to screening and/or during the entire trial period
- Strenuous exercise (as judged by the trial physician) within the last 4 days prior to screening (Visit 1)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Single Centre, Single Dose Trial, Assessing the Pharmacokinetics of NNC172-2021, Administered Subcutaneously at Two Different Dose Levels, in Healthy Japanese Subjects
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (how the trial drug is distributed in the body) of NNC172-2021 administered subcutaneously, at two different dose levels, in healthy Japanese subjects.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy
- Being tested
- NNC172-2021, placebo
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC172-2021Drug
One injection administered subcutaneously (s.c., under the skin). Injection of maximum 1.2 mL
placeboDrug
One injection administered subcutaneously (s.c., under the skin)
| Study group | Role | What they receive |
|---|---|---|
| NNC172-2021 low dose / Placebo | Experimental | Not described Receives: Drug: NNC172-2021; Drug: placebo |
| NNC172-2021 high dose / Placebo | Experimental | Not described Receives: Drug: NNC172-2021; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021
Measured: Week 5
Secondary outcomes (7)
Maximal concentration of NNC172-2021 (Cmax)
Measured: Week 5
Time point for maximal concentration (tmax)
Measured: Week 5
Terminal half-life (t1/2)
Measured: Week 5
Number of adverse events (AEs)
Measured: Week 5
Presence of antibodies against NNC172-2021
Measured: Week 5
Residual tissue factor pathway inhibitor (TFPI) functionality measured by coagulation factor Xa (FXa) generation
Measured: Week 5
TFPI concentration measured by tissue factor pathway inhibitor (TFPI) enzyme-linked immunosorbent assay (ELISA)
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study start12 Mar 2012
- Primary completion8 May 2012
- Study completion8 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Bleeding DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555749
- Sponsor's protocol ID
- NN7415-3981
- Other IDs
- 2011-004575-36, U1111-1124-5137
- Status last verified
- Feb 2017
- First submitted
- 13 Mar 2012
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Single Centre, Single Dose Trial, Assessing the Pharmacokinetics of NNC172-2021, Administered Subcutaneously at Two Different Dose Levels, in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT01555749
- Acronym / sponsor ID
- NN7415-3981
- Conditions
- Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2012 (actual)
- Primary completion
- 8 May 2012 (actual)
- Study completion
- 8 May 2012 (actual)
- First posted
- 15 Mar 2012 (estimated)
- 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.
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (how the trial drug is distributed in the body) of NNC172-2021 administered subcutaneously, at two different dose levels, in healthy Japanese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NNC172-2021 low dose / Placebo | Experimental | Drug: NNC172-2021, Drug: placebo |
| NNC172-2021 high dose / Placebo | Experimental | Drug: NNC172-2021, Drug: placebo |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male Japanese subjects defined as: Subjects born in Japan, time residing outside of Japan does not exceed 5 years, both parents and all 4 grandparents of Japanese descent
- Body weight between 50 and 100 kg, both inclusive
- Body mass index (BMI) between 18.0 and 30.0 kg/m^2, both inclusive
Key exclusion criteria (13 listed)
- Male subjects who are sexually active and not surgically sterilised who, or whose partner, are unwilling to use two different forms of effective contraception, one of which has to be a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 3 months following the last dose of trial medication
- Planned surgery 30 days prior to trial product administration and/or during the entire trial period
- Known hepatic dysfunction during the last 12 months prior to screening (Visit 1)
- Positive urine test for drugs of abuse
- Active hepatitis B and/or hepatitis C infection
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 |
|---|---|---|
| NNC172-2021One injection administered subcutaneously (s.c., under the skin). Injection of maximum 1.2 mL | Drug | NNC172-2021 high dose / Placebo, NNC172-2021 low dose / Placebo |
| placeboOne injection administered subcutaneously (s.c., under the skin) | Drug | NNC172-2021 high dose / Placebo, NNC172-2021 low dose / Placebo |
Primary outcome
Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021
Time frame: Week 5
7 secondary outcomes
Maximal concentration of NNC172-2021 (Cmax)
Time frame: Week 5
Time point for maximal concentration (tmax)
Time frame: Week 5
Terminal half-life (t1/2)
Time frame: Week 5
Number of adverse events (AEs)
Time frame: Week 5
Presence of antibodies against NNC172-2021
Time frame: Week 5
Residual tissue factor pathway inhibitor (TFPI) functionality measured by coagulation factor Xa (FXa) generation
Time frame: Week 5
TFPI concentration measured by tissue factor pathway inhibitor (TFPI) enzyme-linked immunosorbent assay (ELISA)
Time frame: Week 5
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 27 Feb 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Congenital Bleeding Disorder
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC172-2021 in people with Congenital Bleeding Disorder and Haemophilia A, run by Novo Nordisk A/S at 1 site in United Kingdom.
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 3 inclusion and 13 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 27 Feb 2017. 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 United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Area under the curve from time point 0 to infinity (AUC0-∞) of NNC172-2021 (time frame: Week 5). 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 27 Feb 2017.