A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT02962440

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion of somapacitan after single subcutaneous dosing in healthy male subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: somapacitan	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Single Centre, Open Label Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Subcutaneous Dosing in Healthy Male Subjects

Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Somapacitan	Drug: somapacitan All subjects will receive one subcutaneous (s.c., under the skin) dose of somapacitan containing [3H]-somapacitan

Arm

Intervention/Treatment

Experimental: Somapacitan

Drug: somapacitan

All subjects will receive one subcutaneous (s.c., under the skin) dose of somapacitan containing [3H]-somapacitan

Outcome Measures

Primary Outcome Measures

Total amount of [3H]-somapacitan related material excreted in urine (% of dose) [Assessed up to 35 days after trial product administration]
Total amount of [3H]-somapacitan related material excreted in faeces (% of dose) [Assessed up to 35 days after trial product administration]
Total amount of [3H]-somapacitan related material excreted in expired air (% of dose) [Assessed up to 35 days after trial product administration]

Secondary Outcome Measures

Total recovery of administered 3H label (sum of urine, faeces and expired air) [Assessed up to 36 days after trial product administration]
Blood to plasma ratio of [3H]-somapacitan related material [Assessed up to 36 days after trial product administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male, aged 45-64 years (both inclusive) at the time of signing informed consent
Body mass index (BMI) 20.0-29.9 kg/m^2 (both inclusive)
Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

Male of reproductive age who or whose partner(s) is not willing to use adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) for at least 4 months after dosing or male who is not willing to refrain from donating semen for at least 4 months after dosing. Acceptable forms of prevention include complete sexual abstinence, surgically sterilisation, that the subject uses a condom during intercourse or that the partner practices adequate contraception (risk of pregnancy must be lower than 1%).
Use of prescription or non-prescription products, including herbal products and non-routine vitamins, within 14 days prior to screening. Occasional use of paracetamol is permitted.
Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Groningen		Netherlands	9728 NZ

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT02962440

Other Study ID Numbers:

NN8640-4237
2016-000096-24
U1111-1178-1251

First Posted:

Nov 11, 2016

Last Update Posted:

Jun 7, 2017

Last Verified:

Jun 1, 2017

Study Results

No Results Posted as of Jun 7, 2017