Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B (Explorer 1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01228669
First received: October 25, 2010
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and subjects with haemophilia A or B


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Healthy
Drug: NNC 0172-0000-2021
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-0000-2021 Administered Intravenously and 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), including Serious Adverse Events (SAEs) [ Time Frame: from trial product administration until 43 days after trial product administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the concentration-time curve [ Time Frame: from 43 days after trial product administration until 53 days after trial product administration ] [ Designated as safety issue: No ]
  • Adverse Events (AEs), including Serious Adverse Events (SAEs) [ Time Frame: from 43 days after trial product administration until 53 days after trial product administration ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: October 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NNC 0172-0000-2021
Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose
Experimental: B Drug: NNC 0172-0000-2021
Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose.
Placebo Comparator: C Drug: placebo
Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body weight between 50 and 100 kg, both inclusive
  • Body mass index (BMI) between 18.0 kg/m2 and 25.0 kg/m2, both inclusive
  • For haemophilia subjects only: Diagnosed with severe haemophilia A or B

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products
  • Surgery planned to occur during the trial
  • Any major and/or orthopaedic surgery within 30 days prior to trial product administration
  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: NCT01228669

Locations
Austria
Wien, Austria, 1090
Denmark
København, Denmark, 2100
Germany
Berlin, Germany, 10249
Malaysia
Kuala Lumpur, Malaysia, 50400
South Africa
Parktown Johannesburg, Gauteng, South Africa, 2193
Spain
Madrid, Spain, 28046
Switzerland
Zürich, Switzerland, 8091
Thailand
Bangkok, Thailand, 10400
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: NCT01228669     History of Changes
Other Study ID Numbers: NN7415-3813, 2010-020465-24, U1111-1116-2356
Study First Received: October 25, 2010
Last Updated: August 25, 2014
Health Authority: Austria: The Austrian Agency for Health and Food Safety (AGES)
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Malaysia: National Pharmaceutical Control Bureau
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines and Health Care Products
Switzerland: Swissmedic
Thailand: Ministry of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on October 22, 2014