Main
|
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: |
|
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
| | | | | | | |
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
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|