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| Name | Class |
|---|---|
| Achillion, a wholly owned subsidiary of Alexion | INDUSTRY |
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This was a randomized, double-blind, double-dummy, placebo- and positive-controlled, 2-arm (Treatment Arm and Control Arm), parallel study to evaluate the effect of ACH-0144471 (danicopan) on the QT interval in healthy adult participants.
Participants randomized to the Treatment Arm received all 3 doses of danicopan in a single ascending fashion over 3 periods (Treatment Sequence ABC). A single oral dose of danicopan was administered with a moxifloxacin-matching placebo on Day 1 of each period.
Participants randomized to the Control Arm were further randomized to receive 1 of 2 treatment sequences (Treatment Sequences EFG or IJK). A single oral dose of danicopan-matching placebo was administered with moxifloxacin or with moxifloxacin-matching placebo, as per the assigned randomization scheme, on Day 1 of each period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm (ABC) | Experimental | Treatment Sequence ABC - Participants received all 3 doses of danicopan in ascending fashion over 3 periods: Treatment A (Period 1): Danicopan 400 milligrams (mg) and moxifloxacin-matching placebo. Treatment B (Period 2): Danicopan 800 mg and moxifloxacin-matching placebo. Treatment C (Period 3): Danicopan 1200 mg and moxifloxacin-matching placebo. |
|
| Control Arm (EFG and IJK) | Placebo Comparator | Participants received 1 of 2 treatment sequences (Treatment Sequence EFG or Treatment Sequence IJK) over 3 periods: Treatment E (Period 1): Danicopan-matching placebo (400 mg) and moxifloxacin-matching placebo. Treatment F (Period 2): Danicopan-matching placebo (800 mg) and moxifloxacin 400 mg. Treatment G (Period 3): Danicopan-matching placebo (1200 mg) and moxifloxacin-matching placebo. Treatment I (Period 1): Danicopan-matching placebo (400 mg) and moxifloxacin 400 mg. Treatment J (Period 2): Danicopan-matching placebo (800 mg) and moxifloxacin-matching placebo. Treatment K (Period 3): Danicopan-matching placebo (1200 mg) and moxifloxacin 400 mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danicopan | Drug | Danicopan tablets administered as a single oral dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected Change From Baseline In QTc Intervals (ddQTc) For Danicopan | Pre-dose through 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline In Heart Rate (HR) For Danicopan | Pre-dose through 24 hours post-dose | |
| Change From Baseline In QT Interval For Danicopan | Pre-dose through 24 hours post-dose | |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| C000718467 | danicopan |
| 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 |
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This was a double-dummy, placebo- and positive-controlled study.
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| Moxifloxacin-matching Placebo | Drug | Moxifloxacin-matching placebo was administered as a single oral dose. |
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| Danicopan-matching placebo | Drug | Danicopan-matching placebo was administered as a single oral dose. |
|
| Moxifloxacin | Drug | Moxifloxacin 400 mg was administered as a single tablet oral dose. |
|
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| Change From Baseline In Pulse Rate (PR) For Danicopan |
| Pre-dose through 24 hours post-dose |
| Change From Baseline In RR Interval For Danicopan | Pre-dose through 24 hours post-dose |
| Change From Baseline In QRS Interval For Danicopan | Pre-dose through 24 hours post-dose |
| ddQTcF Of Moxifloxacin | Pre-dose through 24 hours post-dose |
| Treatment-emergent T-wave Morphology Abnormalities And Pathologic U-waves | Pre-dose through 24 hours post-dose |
| Area Under The Plasma Concentration Versus Time Curve From Time 0 To 24 Hours Post-dose (AUC0-24) Of Danicopan | Pre-dose through 24 hours post-dose |
| Maximum Observed Plasma Concentration (Cmax) Of Danicopan | Pre-dose through 24 hours post-dose |
| Time To Reach The Maximum Observed Plasma Concentration (Tmax) Of Danicopan | Pre-dose through 24 hours post-dose |
| Number Of Participants Experiencing Treatment-emergent Adverse Events | Day 1 (postdose) through follow-up visit (14 [+/- 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 |