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A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone Disorder; Adult Growth Hormone Deficiency

Intervention: NNC0195-0092 (Drug); Norditropin NordiFlex® (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Lene Finnerup Nielsen, Study Director, Affiliation: Novo Nordisk A/S

Summary

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092) compared to once daily Norditropin NordiFlex in adults with growth hormone deficiency (GHD).

Clinical Details

Official title: A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092) Compared to Once-daily Norditropin NordiFlex in Adults With Growth Hormone Deficiency

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of adverse events (AEs)

Secondary outcome:

NNC0195-0092 only: Area under the curve, AUC (0-168h)

Norditropin NordiFlex® only: AUC (0-24h)

NNC0195-0092, first dose administration only: AUC (0-168h)

Norditropin NordiFlex®, first dose administration only: AUC (0-24h)

NNC0195-0092: Maximum serum concentration (Cmax)

Norditropin NordiFlex®: Cmax

Insulin-like growth factor I (IGF-I): AUC (0-168h)

IGF-I: Cmax

Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h)

IGFBP-3: Cmax

Eligibility

Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adults with GHD as defined in the consensus guidelines for the diagnosis and

treatment of adults with GHD

- Stable human growth hormone (hGH) replacement therapy for at least 3 months

Exclusion Criteria:

- Participation in another clinical trial within 3 months or receipt of any

investigational medicinal product within 3 months prior to randomisation

- Active malignant disease or malignant disease within the last 5 years with exception

of fully treated local basal cell carcinoma or carcinoma in situ of cervix

- Proliferative retinopathy judged by retina-photo within the last year - only with

concomitant diabetes

- Heart insufficiency, New York Heart Association (NYHA) class above 2

- Adults with GHD with poorly controlled diabetes mellitus with a glycosylated

haemoglobin (HbA1c) 64 mmol/mol (8. 0%) and/or insulin treatment

- Stable pituitary replacement therapy for less than 3 months

Locations and Contacts

København Ø 2100, Denmark

Stockholm 141 86, Sweden

Additional Information

Clinical Trials at Novo Nordisk

Starting date: October 2012
Last updated: November 26, 2013

Page last updated: August 23, 2015

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