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

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01686555
• Collaborator: (none)
• Enrollment: 97
• Locations: 15
• Arms: 2
• Duration (Months): 30.9
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus	Drug: ABT-199; Other: Placebo	Phase 1

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official 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)
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Dose Subjects enrolled in the Single Ascending Dose (SAD) part of the study will receive a single dose of study drug or placebo. (Groups 1, 2, 3, 4, 5 and 6).	Drug: ABT-199; Tablet; Other: Placebo; Tablet
Experimental: Multiple Dose Subjects enrolled in the Multiple Ascending Dose (MAD) part of the study will receive multiple doses of study drug or placebo. (Groups 7, 8, 9, 10 and 11)	Drug: ABT-199; Tablet; Other: Placebo; Tablet

Outcome Measures

Primary Outcome Measures

1. Number of participants with Adverse Events [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 [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 [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 [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 [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 [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 [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 [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 Outcome Measures

1. Measurement of lymphocyte depletion and recovery [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 89694	Clearwater	Florida	United States	33765
2	Site Reference ID/Investigator# 131720	DeBary	Florida	United States	32713
3	Site Reference ID/Investigator# 124116	Miami Lakes	Florida	United States	33016
4	Site Reference ID/Investigator# 118637	Miami	Florida	United States	33136
5	Site Reference ID/Investigator# 89693	Orlando	Florida	United States	32806
6	Site Reference ID/Investigator# 78256	Overland Park	Kansas	United States	66212
7	Site Reference ID/Investigator# 129826	Rochester	Minnesota	United States	55905
8	Site Reference ID/Investigator# 89773	Manhasset	New York	United States	11030
9	Site Reference ID/Investigator# 78254	Duncansville	Pennsylvania	United States	16635
10	Site Reference ID/Investigator# 123335	Dallas	Texas	United States	75231
11	Site Reference ID/Investigator# 78253	Dallas	Texas	United States	75231
12	Site Reference ID/Investigator# 107896	Berlin		Germany	10117
13	Site Reference ID/Investigator# 116395	Distrito Federal		Mexico	CP 14050
14	Site Reference ID/Investigator# 112555	Monterrey		Mexico	C.P. 64000
15	Site Reference ID/Investigator# 132009	San Juan		Puerto Rico	00909-3004

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Peng Lu, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01686555
• Other Study ID Numbers: M13-093; 2013-000328-33
• First Posted: Sep 18, 2012
• Last Update Posted: Nov 20, 2017
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Venetoclax

Study Results

No Results Posted as of Nov 20, 2017