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A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects (explorer™2)

This study has been terminated.
(See detailed description)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01631942
First received: June 28, 2012
Last updated: November 12, 2014
Last verified: November 2014
  Purpose

This trial is conducted in Europe. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Healthy
Drug: NNC172-2021
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number of adverse events (AEs) [ Time Frame: From first trial drug administration through trial day 35 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Local tolerability [ Time Frame: After the last s.c. dose administration (trial day 15) ] [ Designated as safety issue: No ]
  • Thrombocyte count [ Time Frame: After the last s.c. dose administration (trial day 15) ] [ Designated as safety issue: No ]
  • Trough level (Ctrough) [ Time Frame: Prior to the last s.c. dose administration (trial day 15) ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose (healthy subjects) Drug: NNC172-2021

Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks.

Escalation to next dose level is based on a safety evaluation.

Experimental: Medium dose (subjects with haemophilia) Drug: NNC172-2021

Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks.

Escalation to next dose level is based on a safety evaluation.

Experimental: High dose (subjects with haemophilia) Drug: NNC172-2021

Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks.

Escalation to next dose level is based on a safety evaluation.


Detailed Description:

The present phase 1 trial has been terminated due to the need for changes in the trial design requiring a new re-designed multiple dosing phase 1 trial. Initiation of this new trial awaits additional non-clinical data.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For haemophilia subjects only: Subjects diagnosed with haemophilia A with a baseline level of Factor VIII or Factor IX below 2% without inhibitors

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products
  • Thrombocyte count below the lower limit of normal range at screening
  • Any clinical signs or known history of thromboembolic events, or subject considered at high risk of thromboembolic events as judged by the investigator or subjects at increased risk of cardiovascular disease as judged by the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631942

Locations
United Kingdom
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01631942     History of Changes
Other Study ID Numbers: NN7415-3986, 2011-005757-32, U1111-1126-0327
Study First Received: June 28, 2012
Last Updated: November 12, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemophilia A
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014