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

Phase 1

Terminated

• Conditions: Haemophilia A; Congenital Bleeding Disorder; Healthy
• Interventions: Drug: NNC172-2021

• Registration Number: NCT01631942
• Lead Sponsor: Novo Nordisk A/S

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.

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 Timeline

• Study Start: 2012-06-26
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-06-29
• Primary Completion: 2012-09-04
• Study Completion: 2012-09-04
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low dose (healthy subjects)	NNC172-2021	-
High dose (subjects with haemophilia)	NNC172-2021	-
Medium dose (subjects with haemophilia)	NNC172-2021	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events (AEs)	From first trial drug administration through trial day 35

Secondary Outcome Measures

Name	Time	Method
Local tolerability	After the last s.c. dose administration (trial day 15)
Thrombocyte count	After the last s.c. dose administration (trial day 15)
Trough level (Ctrough)	Prior to the last s.c. dose administration (trial day 15)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Harrow, United Kingdom