Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects

NCT01505491 | Completed Phase 1 Results

• 1 other identifier: 1297.1
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 2

Brief Summary

This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to establish pharmacokinetic equivalence of BI 695501 to adalimumab.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)

  Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.

  1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration

• Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)

  Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.

  1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration

• Maximum Measured Concentration of the BI 695501 in Plasma (Cmax)

  Maximum measured concentration of the BI 695501 in plasma (Cmax). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.

  1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration

Secondary Outcomes (2)

• Terminal Half- Life of the BI 695501 in Plasma (t1/2)

  1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration

• Apparent Clearance of the BI 695501 in the Plasma After Extra-vascular Administration (CL/F)

  1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration

Study Arms (3)

BI 695501

EXPERIMENTAL

Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501

Drug: BI695501

adalimumab - US

ACTIVE COMPARATOR

Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab

Drug: adalimumab

adalimumab - EU

ACTIVE COMPARATOR

Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab

Drug: adalimumab

Interventions

adalimumab DRUG

40mg adalimumab single s.c. injection

adalimumab - EU

BI695501 DRUG

BI 695501 single s.c injection

BI 695501

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males
• Body mass index (BMI) =18.5 to =29.9 kg/m2

You may not qualify if:

• Any clinically relevant abnormal finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant previous or concomitant disease as judged by the investigator.
• Chronic or relevant acute infections. A negative result for Human Immunodeficiency Virus, Hepatitis B and Hepatitis C testing is required for participation.
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of prescribed or over-the-counter drugs with a long half-life (\>24 hours) within at least one month or less than 5 half-lives of the respective drug prior to administration or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking during days of confinement at the study center
• Alcohol abuse (average more than 30 g/day)
• Current drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

1297.1.002 Boehringer Ingelheim Investigational Site

Auckland, New Zealand

Location

1297.1.001 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand

Location

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 6, 2012
• Study Start: December 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 20, 2019
• Results First Posted: February 20, 2019

Record last verified: 2018-10

Locations

NZ (2)