explorer™2: 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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01631942
• Collaborator: (none)
• Enrollment: 4
• Locations: 6
• Arms: 3
• Actual Duration (Months): 2.3
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Congenital Bleeding Disorder; Haemophilia A; Healthy	Drug: NNC172-2021	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Actual Study Start Date: Jun 26, 2012
• Actual Primary Completion Date: Sep 4, 2012
• Actual Study Completion Date: Sep 4, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Number of adverse events (AEs) [From first trial drug administration through trial day 35]

Secondary Outcome Measures

1. Local tolerability [After the last s.c. dose administration (trial day 15)]

2. Thrombocyte count [After the last s.c. dose administration (trial day 15)]

3. Trough level (Ctrough) [Prior to the last s.c. dose administration (trial day 15)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Wien		Austria	1090
2	Novo Nordisk Investigational Site	Lyon		France	69003
3	Novo Nordisk Investigational Site	Montpellier		France	34295
4	Novo Nordisk Investigational Site	Berlin		Germany	10249
5	Novo Nordisk Investigational Site	Madrid		Spain	28046
6	Novo Nordisk Investigational Site	Harrow		United Kingdom	HA1 3UJ

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01631942
• Other Study ID Numbers: NN7415-3986; 2011-005757-32; U1111-1126-0327
• First Posted: Jun 29, 2012
• Last Update Posted: May 15, 2019
• Last Verified: May 1, 2019

• Additional relevant MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders

Study Results

No Results Posted as of May 15, 2019