Wilson Disease Clinical Trial
Official title:
A Phase 1, Randomized, 2-Period, 2-Sequence, Cross-over Study to Determine the Effect of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.
Verified date | October 2022 |
Source | Alexion |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This was a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of celecoxib, a sensitive cytochrome P450 2C9 (CYP2C9) substrate, in healthy male and female participants. The safety and tolerability of ALXN1840 were determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via total molybdenum with the coadministration of celecoxib.
Status | Completed |
Enrollment | 36 |
Est. completion date | November 3, 2020 |
Est. primary completion date | November 3, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Adequate venous access in the left or right arm to allow the collection of blood samples. - Bodyweight = 45 to = 100 kilograms (kg) and body mass index within the range of 18 to < 30 kg/meter squared. - Willing and able to follow protocol-specified contraception requirements. - Capable of giving signed informed consent. Exclusion Criteria: - History or presence of/significant medical history. - Clinically significant multiple or severe allergies. - Lymphoma, leukemia, or any malignancy within 5 years. - Breast cancer within the past 10 years. - Serum creatinine > upper limit of normal (ULN) of the reference range. - Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > ULN. - Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). - QTc > 450 milliseconds (msec) for male participants or > 470 msec for female participants. |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Trial Site | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Alexion |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Observed Plasma Concentration (Cmax) Of Celecoxib With And Without The Coadministration Of ALXN1840 | Blood samples were collected for pharmacokinetics (PK) analysis of celecoxib. Cmax is reported as nanograms (ng)/milliliter (mL). | Baseline, up to 336 hours post-dose | |
Primary | Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUCt) Of Celecoxib With And Without The Coadministration Of ALXN1840 | Blood samples were collected for pharmacokinetic (PK) analysis of celecoxib. Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUCt) is reported as hours•ng/mL (h•ng/mL). | Baseline, up to 336 hours post-dose | |
Primary | Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) Of Celecoxib With And Without The Coadministration Of ALXN1840 | Blood samples were collected for pharmacokinetic (PK) analysis of celecoxib. Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) is reported as h•ng/mL. | Baseline, up to 336 hours post-dose | |
Secondary | Cmax Of Molybdenum With Coadministration Of Celecoxib | Blood samples were collected for PK analysis of total molybdenum (as a measure of ALXN1840) and plasma ultrafiltrate (PUF) molybdenum. Cmax is reported as ng/mL. | Baseline, up to 336 hours post-dose | |
Secondary | AUCt Of Molybdenum With Coadministration Of Celecoxib | Blood samples were collected for PK analysis of total molybdenum (as a measure of ALXN1840) and PUF molybdenum. AUCt is reported as h•ng/mL. | Baseline, up to 336 hours post-dose | |
Secondary | AUCinf Of Molybdenum With Coadministration Of Celecoxib | Blood samples were collected for PK analysis of total molybdenum (as a measure of ALXN1840) and PUF molybdenum. AUCinf is reported as h•ng/mL. | Baseline, up to 336 hours post-dose |
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