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:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01228669
First received: October 25, 2010
Last updated: September 12, 2012
Last verified: September 2012
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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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228669
Locations
| Austria | |
| Wien, Austria, A 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
Investigators
| Study Director: | Ute Friedrich | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01228669 History of Changes |
| Other Study ID Numbers: | NN7415-3813, U1111-1116-2356, 2010-020465-24 |
| Study First Received: | October 25, 2010 |
| Last Updated: | September 12, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA) Germany: Federal Institute for Drugs and Medical Devices Thailand: Ministry of Public Health Denmark: Danish Medicines Agency Austria: The Austrian Agency for Health and Food Safety (AGES) Sweden: Medical Products Agency Italy: Ministry of Health Switzerland: Swissmedic Malaysia: National Pharmaceutical Control Bureau Turkey: Ministry of Health South Africa: Medicines Control Council Spain: Spanish Agency of Medicines and Health Care Products |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Hemophilia B Hemophilia A Hemorrhage Hematologic Diseases |
Vascular Diseases Cardiovascular Diseases Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Genetic Diseases, Inborn Genetic Diseases, X-Linked Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013