Growth Hormone DisorderPhase 1NCT00722540
Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
A Phase 1 study testing NNC126-0083 in people with Growth Hormone Disorder and Healthy, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Disorder, Healthy
- What is being tested?
- NNC126-0083
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2008to Apr 2009
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects with Japanese passport and Japanese born parents
- Body Mass Index (BMI, kg/m2) between 18.0 and 27.0, both inclusive
- Subjects must be in good health according to age
Who cannot join
- A history or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases
- History of any illnesses or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject
- Any clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NCC126-0083 in Healthy Male Japanese Subjects.
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male Japanese subjects.
- Conditions
- Growth Hormone Disorder, Healthy
- Being tested
- NNC126-0083, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC126-0083Drug
Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
NNC126-0083Drug
Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
NNC126-0083Drug
Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
NNC126-0083Drug
Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
placeboDrug
Dose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
placeboDrug
Dose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
placeboDrug
Dose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
placeboDrug
Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
NNC126-0083Drug
Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks
placeboDrug
Dose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: NNC126-0083; Drug: placebo |
| B | Experimental | Not described Receives: Drug: NNC126-0083; Drug: placebo |
| C | Experimental | Not described Receives: Drug: NNC126-0083; Drug: placebo |
| D | Experimental | Not described Receives: Drug: NNC126-0083; Drug: placebo |
| E | Experimental | Not described Receives: Drug: NNC126-0083; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (adverse events, local tolerability, physical examination)
Measured: 0 to 10 days after third dosing, (day 15-25 after first dose)
Secondary outcomes (1)
Cmax, maximum concentration of IGF-I
Measured: 7 days after first dosing and 10 days after the third dosing (day 1-25 after first dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 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
- NCT00722540
- Sponsor's protocol ID
- NN8630-1958
- Other IDs
- 2008-001578-33, 2008
- Status last verified
- Feb 2017
- First submitted
- 23 Jul 2008
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Rasmussen MH, Jensen L, Anderson TW, Klitgaard T, Madsen J. Multiple doses of pegylated long-acting growth hormone are well tolerated in healthy male volunteers and possess a potential once-weekly treatment profile. Clin Endocrinol (Oxf). 2010 Dec;73(6):769-76. doi: 10.1111/j.1365-2265.2010.03863.x.
PubMed 20718773
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NCC126-0083 in Healthy Male Japanese Subjects.
- ClinicalTrials.gov ID
- NCT00722540
- Acronym / sponsor ID
- NN8630-1958
- Conditions
- Growth Hormone Disorder, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Jul 2008 (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 clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male Japanese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: NNC126-0083, Drug: placebo |
| B | Experimental | Drug: NNC126-0083, Drug: placebo |
| C | Experimental | Drug: NNC126-0083, Drug: placebo |
| D | Experimental | Drug: NNC126-0083, Drug: placebo |
| E | Experimental | Drug: NNC126-0083, Drug: placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects with Japanese passport and Japanese born parents
- Body Mass Index (BMI, kg/m2) between 18.0 and 27.0, both inclusive
- Subjects must be in good health according to age
Key exclusion criteria (3 listed)
- A history or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases
- History of any illnesses or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject
- Any clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator
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 |
|---|---|---|
| NNC126-0083Dose level 1; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks | Drug | A |
| NNC126-0083Dose level 2; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks | Drug | B |
| NNC126-0083Dose level 3; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks | Drug | C |
| NNC126-0083Dose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks | Drug | D |
| placeboDose level 1; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks | Drug | A |
| placeboDose level 2; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks | Drug | B |
| placeboDose level 3; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks | Drug | C |
| placeboDose level 3 repeated; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks | Drug | D |
| NNC126-0083Dose level 4; (6 subjects active, 2 subjects placebo); s.c. injection once weekly for 3 weeks | Drug | E |
| placeboDose level 4; NNC126-0083 placebo for s.c. injection once weekly for 3 weeks | Drug | E |
Primary outcome
Safety and tolerability (adverse events, local tolerability, physical examination)
Time frame: 0 to 10 days after third dosing, (day 15-25 after first dose)
1 secondary outcome
Cmax, maximum concentration of IGF-I
Time frame: 7 days after first dosing and 10 days after the third dosing (day 1-25 after first dose)
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 8 Feb 2017.
- Results publication: PubMed 20718773Rasmussen MH, Jensen L, Anderson TW, Klitgaard T, Madsen J. Multiple doses of pegylated long-acting growth hormone are well tolerated in healthy male volunteers and possess a potential once-weekly treatment profile. Clin Endocrinol (Oxf). 2010 Dec;73(6):769-76. doi: 10.1111/j.1365-2265.2010.03863.x.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
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 NNC126-0083 in people with Growth Hormone Disorder and Healthy, run by Novo Nordisk A/S at 1 site in Germany.
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 3 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 8 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 Germany. 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?
Safety and tolerability (adverse events, local tolerability, physical examination) (time frame: 0 to 10 days after third dosing, (day 15-25 after first dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00722540, which also lists 1 linked publication.
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 8 Feb 2017.