Growth DisorderPhase 1NCT01512095
Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers
A Phase 1 study testing somatropin in people with Growth Disorder and Healthy, run by Novo Nordisk A/S.
Trial summary
This trial is conducted in Europe and United States of America (USA). The aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® versus Nutropin AQ® in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Growth Disorder, Healthy
- What is being tested?
- somatropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Nov 2013
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- No previous exposure to recombinant human GH (growth hormone)or IGF-I (insulin-like growth factor-I)
- Body mass index (BMI) 18.0-27.0 kg/m^2 (both inclusive)
- Considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results, and electrocardiogram (ECG), as judged by the Investigator
Who cannot join
- The receipt of any investigational medicinal product within 1 month prior to this trial
- Current or previous treatment with recombinant human growth hormone or IGF-I
- Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures as required by local law) for the duration of the trial
- Known presence or history of malignancy
- Diabetes mellitus
- Use of pharmacologic doses of glucocorticoids
- Use of anabolic steroids
- History of drug or alcohol abuse
About this study
Official title: A Trial to Examine the Bioequivalence of Norditropin® Versus Nutropin AQ® in Healthy Adult Volunteers
This trial is conducted in Europe and United States of America (USA). The aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® versus Nutropin AQ® in healthy adult volunteers.
- Conditions
- Growth Disorder, Healthy
- Being tested
- somatropin
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period
somatropinDrug
A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period
| Study group | Role | What they receive |
|---|---|---|
| Norditropin® | Experimental | Not described Receives: Drug: somatropin |
| Nutropin AQ® | Active comparator | Not described Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum hGH (human growth hormone) concentration-time curve (AUC0-t)
Measured: From 0 to the time of the last quantifiable concentration over a 24-hour sampling period
Maximum observed serum hGH concentration
Measured: Over a 24-hour sampling period
Area under the effect (IGF-I) curve from time 0 to the time of the last concentration (AUEC0-t)
Measured: Over a 96-hour sampling period
Maximum IGF-I (insulin-like growth factor-I) effect (Emax)
Measured: Over a 96-hour sampling period
Secondary outcomes (7)
The frequency of adverse events (AE) and vital signs
Measured: From screening (14 days before randomisation) to follow-up period (3-21 days after randomisation)
The frequency of abnormal hematology
Measured: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
The frequency of abnormal findings in physical examinations
Measured: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
Biochemistry laboratory parameters
Measured: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
The frequency of injection site reaction
Measured: From the time of injection of the trial product (day 1 and day 13) to follow-up during the two dosing periods (day 5 and day 17)
Area under the effect (IGFBP-3) curve
Measured: From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period
Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax)
Measured: Over a 96-hour sampling period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startAug 2013
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Germak, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512095
- Sponsor's protocol ID
- GH-3958
- Other IDs
- 2012-003381-40, U1111-1122-9661
- Status last verified
- Sep 2013
- First submitted
- 9 Jan 2012
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Examine the Bioequivalence of Norditropin® Versus Nutropin AQ® in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01512095
- Acronym / sponsor ID
- GH-3958
- Conditions
- Growth Disorder, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 19 Jan 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 and United States of America (USA). The aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® versus Nutropin AQ® in healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norditropin® | Experimental | Drug: somatropin |
| Nutropin AQ® | Active comparator | Drug: somatropin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No previous exposure to recombinant human GH (growth hormone)or IGF-I (insulin-like growth factor-I)
- Body mass index (BMI) 18.0-27.0 kg/m^2 (both inclusive)
- Considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results, and electrocardiogram (ECG), as judged by the Investigator
Key exclusion criteria (8 listed)
- The receipt of any investigational medicinal product within 1 month prior to this trial
- Current or previous treatment with recombinant human growth hormone or IGF-I
- Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures as required by local law) for the duration of the trial
- Known presence or history of malignancy
- Diabetes mellitus
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 |
|---|---|---|
| somatropinA single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period | Drug | Norditropin® |
| somatropinA single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period | Drug | Nutropin AQ® |
Primary outcome
Area under the serum hGH (human growth hormone) concentration-time curve (AUC0-t)
Time frame: From 0 to the time of the last quantifiable concentration over a 24-hour sampling period
Maximum observed serum hGH concentration
Time frame: Over a 24-hour sampling period
Area under the effect (IGF-I) curve from time 0 to the time of the last concentration (AUEC0-t)
Time frame: Over a 96-hour sampling period
Maximum IGF-I (insulin-like growth factor-I) effect (Emax)
Time frame: Over a 96-hour sampling period
7 secondary outcomes
The frequency of adverse events (AE) and vital signs
Time frame: From screening (14 days before randomisation) to follow-up period (3-21 days after randomisation)
The frequency of abnormal hematology
Time frame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
The frequency of abnormal findings in physical examinations
Time frame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
Biochemistry laboratory parameters
Time frame: From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation)
The frequency of injection site reaction
Time frame: From the time of injection of the trial product (day 1 and day 13) to follow-up during the two dosing periods (day 5 and day 17)
Area under the effect (IGFBP-3) curve
Time frame: From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period
Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax)
Time frame: Over a 96-hour sampling period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
- 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.
John Germak study director
Novo Nordisk A/S
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing somatropin in people with Growth Disorder and Healthy, run by Novo Nordisk A/S.
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 8 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: withdrawn, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 serum hGH (human growth hormone) concentration-time curve (AUC0-t) (time frame: From 0 to the time of the last quantifiable concentration over a 24-hour sampling period). The study lists 4 primary outcomes in all. 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 16 Sep 2013.