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Completed

NCT Number: NCT01686555

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)

To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.

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Key information

Conditions

Lupus Erythematosus

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Site Reference ID/Investigator# 107896, Berlin, Germany

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About this study

This is a phase 1, randomized, double-blind, placebo-controlled, single-and multiple ascending dose study. Up to eighty-eight subjects with Systemic Lupus Erythematosus will be selected to participate. Subjects will be randomized to receive either ABT-199 or placebo. Subjects will be administered ABT-199/placebo as a single dose or up to 14 days as multiple doses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of systemic lupus erythematosus for at least 6 months.
  • Documentation of at least one of the following: ANA titer >= 1:160 or positive anti-dsDNA antibodies.
  • Stable systemic lupus erythematosus medication regimen.
  • Other than systemic lupus erythematosus, subject should be in general good health.

Exclusion criteria

  • Male.
  • Drug-induced or highly active systemic lupus erythematosus.
  • Significant autoimmune disease other than lupus.
  • Significant, uncontrolled or unstable disease in any organ.

Treatment and study plan

ABT-199

Drug

Tablet

Placebo

Other

Tablet

Primary outcomes

  1. Number of participants with Adverse Events

    Time frame: From first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199

    Collect all adverse events at each visit

  2. Physical Exam including vital signs

    Time frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199

    Blood pressure, heart rate and body temperature

  3. Clinical Lab Testing

    Time frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199

    Hematology, Chemistry, and Urinalysis

  4. Electrocardiogram (ECG) Measurements

    Time frame: For 24 hours after a single dose of ABT-199 and up to 24 hours after the seventh dose of multiple doses of ABT-199

    ECGs done in triplicate

  5. Maximum observed serum concentration (Cmax) of ABT-199

    Time frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199

    Cmax

  6. Time to Cmax (Tmax) of ABT-199

    Time frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199

    Time to Cmax

  7. The area under the time curve (AUC) of ABT-199

    Time frame: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199

    the area under the exposure-time curve of ABT-199 extrapolated to infinite time for single doses and up to 24 hrs for multiple doses of ABT-199

  8. The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199

    Time frame: For 72 hours after a single dose of ABT-199

    The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199

Secondary outcomes

  1. Measurement of lymphocyte depletion and recovery

    Time frame: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199

    explore pharmacokinetic/pharmacodynamic relationship

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 18, 2012
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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