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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03186495
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 5
• Actual Duration (Months): 10.9
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

The trial is conducted in Europe. The aim of the trial is to investigate the steady state exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate, severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal renal function

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Disorder; Adult Growth Hormone Deficiency; Growth Hormone Deficiency in Children	Drug: Somapacitan	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Jun 20, 2017
• Actual Primary Completion Date: May 17, 2018
• Actual Study Completion Date: May 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal renal function Subjects with normal renal function	Drug: Somapacitan; All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan
Experimental: Mild renal impairment Subjects with mild renal impairment	Drug: Somapacitan; All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan
Experimental: Moderate renal impairment Subjects with moderate renal impairment	Drug: Somapacitan; All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan
Experimental: Severe renal impairment Subjects with severe renal impairment	Drug: Somapacitan; All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan
Experimental: Requiring haemodialysis treatment Subjects requiring haemodialysis treatment	Drug: Somapacitan; All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan

Outcome Measures

Primary Outcome Measures

1. Area under the somapacitan serum concentration time curve [From time 0 to 168 hours after the last dosing on Day 15.]

   Calculated based on the serum concentrations measured in ug/l

Secondary Outcome Measures

1. Maximum serum concentration of somapacitan [After the last dosing on Day 15 up until Day 43]

   Measured in ng/ml

2. Time to maximum serum concentration of somapacitan [After the last dosing on Day 15 up until Day 43]

   Calculated based on the serum concentrations measured in ug/l

3. Incidence of adverse events [Day 0 - 43]

   Count and % of events

4. Occurrence of anti-somapacitan antibodies [Day 0 - 43]

   Count or % of events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 (Inutest®) 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Berlin		Germany	10117

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03186495
• Other Study ID Numbers: NN8640-4297; U1111-1187-9141; 2016-003910-29
• First Posted: Jun 14, 2017
• Last Update Posted: Apr 17, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Dwarfism, Pituitary; Renal Insufficiency; Endocrine System Diseases

Study Results

No Results Posted as of Apr 17, 2020