Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Celerion | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blind, double-dummy, placebo- and positive-controlled parallel study to evaluate the effect of ALXN2050 on the QT interval in healthy adult participants.
Participants randomized to the treatment arm will receive ALXN2050 in a multiple-ascending doses fashion over 3 periods (treatment sequence ABC). Participants randomized to the control arms will be further randomized to 1 of 2 treatment sequences (treatment sequence DEF or GHI) to receive placebo or active control over 3 periods.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm (ABC) | Experimental | Treatment Sequence ABC - Participants will receive all 3 doses of ALXN2050 in a multiple-ascending fashion over 3 periods: Treatment A (Period 1): ALXN2050 Dose 120 milligrams (mg) and moxifloxacin-matching placebo. Treatment B (Period 2): ALXN2050 Dose 240 mg and moxifloxacin-matching placebo. Treatment C (Period 3): ALXN2050 Dose 360 mg and moxifloxacin-matching placebo. |
|
| Control Arm (DEF) | Placebo Comparator | Treatment Sequence DEF - Participants will receive ALXN2050-matching placebo over 3 periods: Treatment D (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin-matching placebo. Treatment E (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin. Treatment F (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin-matching placebo. |
|
| Control Arm (GHI) | Placebo Comparator | Treatment Sequence GHI - Participants will receive ALXN2050-matching placebo over 3 periods: Treatment G (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin. Treatment H (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin-matching placebo. Treatment I (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN2050 | Drug | ALXN2050 will be administered orally twice daily as powder-in-capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected Change From Baseline QTc Intervals (ddQTc) For ALXN2050 | Twelve-lead electrocardiograms (ECGs) will be extracted from continuous (Holter) recordings. | Pre-dose through 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline PR Interval (dPR) For ALXN2050 | Twelve-lead ECGs will be extracted from continuous (Holter) recordings. | Pre-dose through 24 hours post-dose |
| ddQTc For Moxifloxacin | Twelve-lead ECGs will be extracted from continuous (Holter) recordings. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Tempe | Arizona | 85283 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020742 | rhoA GTP-Binding Protein |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D020741 | rho GTP-Binding Proteins |
| D020559 | Monomeric GTP-Binding Proteins |
| D019204 | GTP-Binding Proteins |
| D020558 | GTP Phosphohydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ALXN2050-matching Placebo | Drug | ALXN2050-matching placebo will be administered orally twice daily as placebo powder-in-capsule. |
|
| Moxifloxacin | Drug | Moxifloxacin will be administered as a single oral dose. |
|
| Moxifloxacin-matching Placebo | Drug | Moxifloxacin-matching placebo will be administered as a single oral dose. |
|
| Pre-dose through 24 hours post-dose |
| Area Under The Plasma Concentration-time Curve During A Dosing Interval (tau) At Steady-state (AUCtau) For ALXN2050 | Pre-dose through 24 hours post-dose |
| Maximum Observed Plasma Concentration Following Multiple Dosing (Cmax,ss) For ALXN2050 | Up to 24 hours postdose |
| Time To Maximum Observed Plasma Concentration Following Multiple Dosing (Tmax,ss) For ALXN2050 | Pre-dose through 24 hours post-dose |
| Incidence Of Treatment-emergent Adverse Events | Day 1 (postdose) through follow-up (7 [+/- 2] days after last study drug administration) |
| D017766 | Acid Anhydride Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |