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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03186495
Date of registration: 12/06/2017
Prospective Registration: Yes
Primary sponsor: Novo Nordisk A/S
Public title: Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
Scientific title: Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
Date of first enrolment: June 20, 2017
Target sample size: 44
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03186495
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
Germany
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female, aged 18-75 years (both inclusive) at the time of signing informed
consent

- Body mass index between 18.5-34.9 kg/sqm (both inclusive)

- Meeting the pre-defined glomerular filtration rate for any of the renal function
groups 1-4 (based on the measured glomerular filtration rate using exogenous sinistrin
(InutestĀ®) as a filtration marker) or being in treatment with haemodialysis

Exclusion Criteria:

- Female who is pregnant, breast-feeding or intends to become pregnant or is of
child-bearing potential and not using an adequate contraceptive method (adequate
contraceptive measure as required by local regulation or practice). Male of
reproductive age who or whose partner(s) is not using adequate contraceptive methods
(adequate contraceptive measures as required by local regulation or practice) or male
who is not willing to refrain from donating semen for at least 16 days after last
trial product administration

- Any disorder, except for conditions associated with renal impairment in the groups of
subjects with reduced renal function, which in the investigator's opinion might
jeopardise subject's safety, evaluation of results, or compliance with the protocol.
For example, arterial hypertension, anaemia, impaired glucose tolerance or type 2
diabetes are accepted in the group of subjects with renal impairment



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Adult Growth Hormone Deficiency
Growth Hormone Deficiency in Children
Growth Hormone Disorder
Intervention(s)
Drug: Somapacitan
Primary Outcome(s)
Area under the somapacitan serum concentration time curve [Time Frame: From time 0 to 168 hours after the last dosing on Day 15.]
Secondary Outcome(s)
Incidence of adverse events [Time Frame: Day 0 - 43]
Occurrence of anti-somapacitan antibodies [Time Frame: Day 0 - 43]
Time to maximum serum concentration of somapacitan [Time Frame: After the last dosing on Day 15 up until Day 43]
Maximum serum concentration of somapacitan [Time Frame: After the last dosing on Day 15 up until Day 43]
Secondary ID(s)
2016-003910-29
U1111-1187-9141
NN8640-4297
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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