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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This study will assess the Bioequivalence between 180 mg and 60 mg ALXN2050 Tablets and the Effect of Food on ALXN2050 Pharmacokinetics.
This is a single-center, open-label, randomized, 3-period crossover study.
Screening of participants will occur within 28 days prior to the first dose of study intervention.
The study will comprise of 3 Treatment Periods: Treatment period 1, Treatment period 2, Treatment period 3. There will be a washout period of at least 4 days between the ALXN2050 dose in each treatment period.
Participants will be enrolled and will be randomized 1:1:1:1:1:1 to receive one of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA).
On the morning of Day 1 of each of the 3 periods, participants will receive one of the following treatments as per the randomization scheme.
Duration of study conduct (screening to follow-up): approximately 47 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence ABC | Experimental | Participants will be administered Treatment A (3 X Dose B of ALXN2050 tablet under fasted conditions), Treatment B (single Dose A of ALXN2050 tablet under fasted conditions) and Treatment C (single Dose A of ALXN2050 tablet with a high-fat meal) on Day 1 of each treatment period. Washout period of at least 4 days between the ALXN2050 dose in each treatment period. |
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| Treatment sequence ACB | Experimental | Participants will be administered Treatment A (3 X Dose B of ALXN2050 tablet under fasted conditions), Treatment C (single Dose A of ALXN2050 tablet with a high-fat meal) and Treatment B (single Dose A of ALXN2050 tablet under fasted conditions) on Day 1 of each treatment period. Washout period of at least 4 days between the ALXN2050 dose in each treatment period. |
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| Treatment sequence BAC | Experimental | Participants will be administered Treatment B (single Dose A of ALXN2050 tablet under fasted conditions), Treatment A (3 X Dose B of ALXN2050 tablet under fasted conditions) and Treatment C (single Dose A of ALXN2050 tablet with a high-fat meal) and on Day 1 of each treatment period. Washout period of at least 4 days between the ALXN2050 dose in each treatment period. |
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| Treatment sequence BCA | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A | Drug | Participants will receive single Dose A dose of ALXN2050 tablet (3 × Dose B) orally under fasted conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Maximum observed plasma (peak) concentration of the drug) | To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet. | Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days) |
| AUCt (Area under the concentration time curve from time zero to the last quantifiable concentration) | To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet. | Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days) |
| AUC∞ (Area under the concentration time curve from time zero extrapolated to infinity) | To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet. | Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days) |
| Tmax (Time corresponding to occurrence of Cmax) | To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet. | Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days) |
| tlag (Time prior to the first measurable (non zero) concentration) | To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet. | Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events (TEAE) and treatment emergent serious adverse events (TESAE) | To assess the safety and tolerability of a single-dose of ALXN2050 when administered as Dose A tablet and Dose B tablets. To assess the safety and tolerability of a single-dose of Dose A ALXN2050 tablet when administered either with or without food. | From Screening (Day - 28 to Day -1) to Follow-up visit ((7 ± 2 days after Final Dose)/EOS) (approximately 47 days) |
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Inclusion Criteria:
Exclusion Criteria:
18. Evidence of hepatitis B (positive hepatitis surface antigen [HBsAg]) or positive core antibody (anti-HBc) with negative surface antibody [anti-HBs]) or hepatitis C viral infection (HCV antibody positive) at screening.
19. Female participants who have a positive pregnancy test. 20. Vital signs out of the normal range as determined by the Investigator including body temperature ≥ 38°C.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | 21225 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
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Participants will be administered Treatment B (single Dose A of ALXN2050 tablet under fasted conditions), Treatment C (single Dose A of ALXN2050 tablet with a high-fat meal) and Treatment A (3 X Dose B of ALXN2050 tablet under fasted conditions) and on Day 1 of each treatment period. Washout period of at least 4 days between the ALXN2050 dose in each treatment period.
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| Treatment sequence CAB | Experimental | Participants will be administered Treatment C (single Dose A of ALXN2050 tablet with a high-fat meal), Treatment A (3 X Dose B of ALXN2050 tablet under fasted conditions) and Treatment B (single Dose A of ALXN2050 tablet under fasted conditions) on Day 1 of each treatment period. Washout period of at least 4 days between the ALXN2050 dose in each treatment period. |
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| Treatment sequence CBA | Experimental | Participants will be administered Treatment C (single Dose A of ALXN2050 tablet with a high-fat meal), Treatment B (single Dose A of ALXN2050 tablet under fasted conditions) and Treatment A (3 X Dose B of ALXN2050 tablet under fasted conditions) on Day 1 of each treatment period. Washout period of at least 4 days between the ALXN2050 dose in each treatment period. |
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| Treatment B | Drug | Participant will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally under fasted conditions. |
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| Treatment C | Drug | Participants will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally with a high-fat meal. |
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| t½ (Apparent terminal elimination half-life) | To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet. | Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days) |
| λz (Terminal elimination rate constant) | To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet. | Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days) |
| CL/F (Apparent clearance) | To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet. | Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days) |
| Vd/F (Apparent volume of distribution during terminal phase) | To compare the single-dose PK of ALXN2050 when administered as Dose A tablet versus Dose B tablets. To determine the effect of food on the single-dose PK of Dose A of ALXN2050 tablet. | Day 1, 2, 3 and 4 (Treatment Period 1, 2, 3) (each treatment period is of 4 days) |