A Phase 2 interventional study of JNJ-54452840 and Placebo in Heart Failure, sponsored by Janssen Research & Development, LLC. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-09.
Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of JNJ-54452840 in participants with heart failure and anti-beta1-adrenergic receptor autoantibodies. The safety and tolerability of JNJ-54452840 will also be assessed.
This study will be randomized (the study treatment is assigned by chance), double-blind (neither investigator nor participant knows the treatment received), and placebo-controlled (one of the study treatments is inactive). This study will be conducted in participants with reduced systolic function heart failure (a reduced amount of blood is pumped around the body compared with a normal heart) and elevated levels of anti-beta1-adrenergic receptor autoantibodies (antibodies that may be involved in development, progression, or worsening of heart failure). The study will be conducted in 2 parts; participants will receive single doses of JNJ-54452840 in Part 1 and multiple doses in Part 2. Each part of the study will consist of 3 phases; a screening phase, a double-blind treatment phase, and a follow-up phase. There will be 2 cohorts (groups) of participants in Part 1 of the study. In Part 1 (Cohort A), participants will be randomly assigned to 1 of 4 treatment groups: a single intravenous (medication is injected into a vein) dose of 20 mg JNJ-54452840; a single intravenous dose of 80 mg JNJ-54452840; a single intravenous dose of 160 mg JNJ-54452840; or matching placebo (inactive medication). In Part 1 (Cohort B), participants will be randomly assigned to 1 of 2 treatment groups; a single intravenous dose of less than or equal to 240 mg JNJ-54452840 (as determined by the Data Review Committee after review of Cohort A data) or matching placebo. There will be 4 cohorts of participants in Part 2 of the study; the dose of JNJ-54452840 used in each cohort, initiation of each cohort, and the sequence will be decided by the Data Review Committee. In Part 2 (Cohort C), participants will be randomly assigned to 1 of 2 treatment groups: JNJ-54452840 or matching placebo given intravenously once daily for 3 days. In Part 2 (Cohort D), participants will be randomly assigned to 1 of 2 treatment groups: JNJ-54452840 or matching placebo given intravenously once daily for 5 days. In Part 2 (Cohort E), participants will be randomly assigned to 1 of 2 treatment groups: JNJ-54452840 or matching placebo given intravenously once weekly on Days 1, 8, 15, and 22. In Part 2 (Cohort F), participants will be randomly assigned to 1 or more treatment groups involving regimen(s) as explored in Cohorts C, D, or E. Single doses of JNJ-54452840 will not be greater than 240 mg for any Cohort. The active to placebo randomization ratio for each cohort following Cohort A (ie, Cohorts B, C, D, E, and F) will be determined by the Data Review Committee. Participants will come to the study center each time they receive study medication and will remain at the center for at least two hours following each injection. Blood samples will be drawn at time points during the screening period and treatment period for participants in both Part 1 and Part 2 of the study. Participants will return to the study center after the double-blind treatment phase on Day 29 and then for follow-up visits on Days 57 and 85. Participants in Part 1 or Part 2 will be involved in the study for approximately 112 days. Participant safety will be monitored. The study drug, JNJ-54452480 is being investigated for the treatment of heart failure.
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Exclusion Criteria:
Each patient will receive 20 mg of JNJ-54452840 as a single dose.
Drug: JNJ-54452840
Each patient will receive 80 mg of JNJ-54452840 as a single dose.
Drug: JNJ-54452840
Each patient will receive 160 mg of JNJ-54452840 as a single dose.
Drug: JNJ-54452840
Each patient will receive matching placebo as a single dose.
Other: Placebo
Each patient will receive JNJ-54452840 at a dose of less than or equal to 240 mg as a single dose (dose determined by the Data Monitoring Committee).
Drug: JNJ-54452840
Each patient will receive matching placebo as a single dose.
Other: Placebo
Each patient will receive JNJ-54452840 once daily for 3 days at a dose determined by the Data Monitoring Committee (daily dose not exceeding 240 mg).
Drug: JNJ-54452840
Each patient will receive matching placebo once daily for 3 days.
Other: Placebo
Each patient will receive JNJ-54452840 once daily for 5 days at a dose determined by the Data Monitoring Committee (daily dose not exceeding 240 mg).
Drug: JNJ-54452840
Each patient will receive matching placebo once daily for 5 days.
Other: Placebo
Each patient will receive JNJ-54452840 once weekly on Days 1, 8, 15, and 22 at a dose determined by the Data Monitoring Committee (daily dose not exceeding 240 mg).
Drug: JNJ-54452840
Each patient will receive matching placebo once weekly on Days 1, 8, 15, and 22.
Other: Placebo
Each patient will receive JNJ-54452840 once daily (for 3 or 5 days) or once weekly (up to Day 22) as determined by the Data Monitoring Committee and as explored in Cohorts C, D, and E (daily dose not exceeding 240 mg).
Drug: JNJ-54452840
Each patient will receive matching placebo once daily (for 3 or 5 days) or once weekly (up to Day 22).
Other: Placebo
Once daily intravenous injection(s) (medication is injected into a vein) at doses ranging from 20 mg to 240 mg, given as a single injection (Cohorts A and B); injections given once daily over 3 to 5 days (Cohorts C, D, and F); or injections given once weekly up to Day 22 (Cohorts E and F).
Once daily matching intravenous injection(s) (medication is injected into a vein) given as a single injection (Cohorts A and B); injections given once daily over 3 to 5 days (Cohorts C, D, and F); or injections given once weekly up to Day 22 (Cohorts E and F).
Serum levels of anti-beta1-adrenergic receptor autoantibody bound JNJ-54452840
Serum levels of bound JNJ-54452840 (ie, amount of drug that is attached to anti-beta1-adrenergic receptor autoantibodies) will be used to determine pharmacokinetic parameters for JNJ-54452840 (measurements describing how the body affects the drug).
Time frame: Up to Day 7
Serum levels of free JNJ-54452840
Serum levels of free JNJ-54452840 (ie, amount of drug that is not attached to anti-beta1-adrenergic receptor autoantibodies) will be used to determine pharmacokinetic parameters for JNJ-54452840 (measurements describing how the body affects the drug).
Time frame: Up to Day 7
Serum levels of total JNJ-54452840
Serum levels of total JNJ-54452840 (ie, bound drug plus free drug) will be used to determine pharmacokinetic parameters for JNJ-54452840 (measurements describing how the body affects the drug).
Time frame: Up to Day 7
Serum levels of anti-beta1-adrenergic receptor autoantibodies
Blood levels of anti-beta1-adrenergic receptor autoantibodies will be used to determine the pharmacodynamics of JNJ-54452840 (ie, how the drug affects the body).
Time frame: Up to Day 85
Beta1-adrenergic receptor activation
Beta1-adrenergic receptor activation will be used to determine the pharmacodynamics of JNJ-54452840 (ie, how the drug affects the body).
Time frame: Up to Day 29
Number of patients with adverse events
Number of patients with adverse events will be used as a measure of safety and tolerability
Time frame: Up to Day 85
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This study is withdrawn, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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