Safety, Tolerability and Pharmacokinetics of NN1731 in Healthy Volunteers

NCT00822185 | Completed Phase 1 Results

• 2 other identifiers: NN1731-3604JapicCTI-090681
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of activated recombinant human coagulation factor VII analogue (NN1731, vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the pharmacokinetics of NN1731 will be examined

Conditions

Congenital Bleeding Disorder; Healthy

Outcome Measures

Primary Outcomes (2)

• Safety (Physical Examination, Vital Signs, ECG, Haematology, Biochemistry, Urinalysis, Coagulation Factors, Coagulation-related Parameters, Injection Site Tolerability and Adverse Events (AE))

  Any safety issue was reported as AE

  between dosing and 2-3 weeks after dosing

• Subjects With Anti-Vatreptacog Alfa Antibody

  Post-dosing samples from subjects were evaluated for the presence of Anti-Vatreptacog alfa antibody

  between dosing, 2-3 weeks after dosing, and 11-13 weeks after dosing

Secondary Outcomes (12)

• Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 and up Until the Last Quantifiable Activity (AUC0-t)

  during 1-2 days after drug administration

• Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 to 24 h (AUC0-24)

  during 1-2 days after drug administration

• Vatreptacog Alfa Clot Activity: Area Under the FVIIa Activity-time Curve From Time 0 h to Infinity (AUC 0-inf)

  during 1-2 days after drug administration

• Vatreptacog Alfa Clot Activity: Maximum FVIIa Activity (Cmax)

  during 1-2 days after drug administration

• Vatreptacog Alfa Clot Activity: FVIIa Activity Measured 5 Min After Administration of NN1731 (C5min)

  during 1-2 days after drug administration

Study Arms (4)

vatreptacog alfa, 5 mcg/kg

EXPERIMENTAL

Drug: vatreptacog alfa (activated); Drug: placebo

vatreptacog alfa, 10 mcg/kg

EXPERIMENTAL

Drug: vatreptacog alfa (activated); Drug: placebo

vatreptacog alfa, 20 mcg/kg

EXPERIMENTAL

Drug: vatreptacog alfa (activated); Drug: placebo

vatreptacog alfa, 30 mcg/kg

EXPERIMENTAL

Drug: vatreptacog alfa (activated); Drug: placebo

Interventions

vatreptacog alfa (activated) DRUG

One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg

vatreptacog alfa, 5 mcg/kg

placebo DRUG

Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg

vatreptacog alfa, 5 mcg/kg

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Japanese male subjects, who are considered to be generally healthy based on assessment of medical history, physical examination and clinical laboratory data at screening, as judged by the Investigator or Sub-investigator
• Body Mass Index (BMI) between 18.0 and 27.0 kg/m\^2 (inclusive)

You may not qualify if:

• Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal electrocardiogram (ECG) findings at the screening, as judged by the Investigator or Sub-investigator
• Presence or history of cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
• Evidence of clinically relevant pathology or a potential thromboembolic risk as judged by the Investigator or Sub-investigator
• Presence or history of atherosclerosis, arteriosclerosis or thromboembolic events
• Any past history of migraine
• Overt bleeding, including from the gastrointestinal tract

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Tokyo, 130-0004, Japan

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Interventions

vatreptacog alfa

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: January 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 5, 2015
• Results First Posted: September 23, 2014

Record last verified: 2014-12

Locations

JP (1)