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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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This is a randomized, blinded, placebo and active-controlled, 4-period, crossover design thorough QT/QTc (TQT) study to evaluate the effect of ABBV-CLS-7262 on cardiac repolarization in healthy adult subjects.
This is a randomized, blinded, placebo and active-controlled, 4-period, crossover study. The study will be double-blinded for ABBV-CLS-7262 (dose 1 or dose 2) and placebo regimens and open-label for moxifloxacin. 72 subjects are planned to be enrolled.
All subjects will receive a single oral dose of 4 different study treatments over 4 separate treatment periods, each separated by a washout period.
On Day 1 of each period, subjects will receive either ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg.
In each period, cardiodynamic ECGs will be collected pre-dose and for 24 hours post-dose and PK blood samples will be collected pre-dose and for 48 hours post-dose. Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet |
|
| Sequence 2 | Experimental | Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet |
|
| Sequence 3 | Experimental | Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet |
|
| Sequence 4 | Experimental | Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-CLS-7262 | Drug | • single oral Dose 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects | To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects. | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effects of ABBV-CLS-7262 on change in electrocardiogram (ECG) parameters | ECG parameters include RR and PR interval, QRS duration and heart rate (HR). | Up to 24 hours |
| To evaluate the sensitivity of QTc measurement using moxifloxacin |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AbbVie Clinical Pharmacology Research Unit (ACPRU) | Grayslake | Illinois | 60030 | United States |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| ABBV-CLS-7262 | Drug | • single oral Dose 2 |
|
| Placebo | Drug | • single oral dose |
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| Moxifloxacin 400mg | Drug | • single oral dose |
|
To evaluate the sensitivity of QTc measurement using moxifloxacin.
| Up to 24 hours |
| To evaluate the effect of ABBV-CLS-7262 on T-wave morphology | To evaluate the effect of ABBV-CLS-7262 on T-wave morphology. | Up to 24 hours |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |