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First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

NCT ID: NCT01514500

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-16

Study Completion Date

2013-03-18

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to assess safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0195-0092 (somapacitan) compared to placebo in healthy male subjects.

Detailed Description

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Conditions

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Growth Hormone Disorder Adult Growth Hormone Deficiency Growth Hormone Deficiency in Children Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single dose (SD)

Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation

Group Type EXPERIMENTAL

somapacitan

Intervention Type DRUG

Administered s.c. (subcutaneously, under the skin)

placebo (somapacitan)

Intervention Type DRUG

Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)

Multiple dose (MD)

Multiple doses administered s.c. (subcutaneously, under the skin). All subjects will be dosed four times with a dosing frequency of once weekly. Escalation to the next dose level will be based on safety evaluation

Group Type EXPERIMENTAL

somapacitan

Intervention Type DRUG

Administered s.c. (subcutaneously, under the skin)

placebo (somapacitan)

Intervention Type DRUG

Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)

Interventions

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somapacitan

Administered s.c. (subcutaneously, under the skin)

Intervention Type DRUG

placebo (somapacitan)

Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)

Intervention Type DRUG

Other Intervention Names

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NNC0195-0092

Eligibility Criteria

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Inclusion Criteria

* Healthy, non-smoking male subjects
* BMI (body mass index) between 18.0 and 28.0 kg/m\^2, both incl.
* Body weight 50 to 100 kg, both incl.

Exclusion Criteria

* Strenuous exercise within 4 days prior to dosing
* Receipt of any investigational medicinal product within 3 months prior to randomisation
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR,1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Neuss, , Germany

Site Status

Countries

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Germany

References

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Juul Kildemoes R, Hojby Rasmussen M, Agerso H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2021 Jan 23;106(2):567-576. doi: 10.1210/clinem/dgaa775.

Reference Type BACKGROUND
PMID: 33313798 (View on PubMed)

Juul RV, Rasmussen MH, Agerso H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5.

Reference Type DERIVED
PMID: 29671202 (View on PubMed)

Rasmussen MH, Olsen MW, Alifrangis L, Klim S, Suntum M. A reversible albumin-binding growth hormone derivative is well tolerated and possesses a potential once-weekly treatment profile. J Clin Endocrinol Metab. 2014 Oct;99(10):E1819-29. doi: 10.1210/jc.2014-1702. Epub 2014 Jul 11.

Reference Type DERIVED
PMID: 25013997 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1119-0539

Identifier Type: OTHER

Identifier Source: secondary_id

2011-000146-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN8640-3915

Identifier Type: -

Identifier Source: org_study_id