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 CYP2B6 Substrate in Healthy Participants
Verified date | October 2022 |
Source | Alexion |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of ALXN1840 on the metabolism of bupropion, a sensitive cytochrome P450 2B6 (CYP2B6) substrate, in healthy male and female participants. The safety and tolerability of ALXN1840 will be determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via total molybdenum with the coadministration of bupropion.
Status | Completed |
Enrollment | 54 |
Est. completion date | May 28, 2021 |
Est. primary completion date | May 28, 2021 |
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. - Body weight = 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 Bupropion With and Without the Coadministration of ALXN1840 | Pre-dose (Day 1) 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 Bupropion With and Without the Coadministration of ALXN1840 | Pre-dose (Day 1) up to 336 hours post-dose | ||
Primary | Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUCinf) of Bupropion With and Without the Coadministration of ALXN1840 | Pre-dose (Day 1) up to 336 hours post-dose | ||
Secondary | Cmax of Hydroxybupropion With and Without the Coadministration of ALXN1840 | Pre-dose (Day 1) up to 336 hours post-dose | ||
Secondary | AUCt of Hydroxybupropion With and Without the Coadministration of ALXN1840 | Pre-dose (Day 1) up to 336 hours post-dose | ||
Secondary | AUCinf of Hydroxybupropion With and Without the Coadministration of ALXN1840 | Pre-dose (Day 1) up to 336 hours post-dose | ||
Secondary | Cmax of Plasma Total Molybdenum With Coadministration of Bupropion | Plasma total molybdenum was assessed as surrogate measures for ALXN1840 PK following coadministration with bupropion HCl salt tablet (Treatment B) only. | Pre-dose (Day 1) up to 336 hours post-dose | |
Secondary | AUCt of Plasma Total Molybdenum With Coadministration of Bupropion | Plasma total molybdenum was assessed as surrogate measures for ALXN1840 PK following coadministration with bupropion HCl salt tablet (Treatment B) only. | Pre-dose (Day 1) up to 336 hours post-dose | |
Secondary | AUCinf of Plasma Total Molybdenum With Coadministration of Bupropion | Plasma total molybdenum was assessed as surrogate measures for ALXN1840 PK following coadministration with bupropion HCl salt tablet (Treatment B) only. | Pre-dose (Day 1) up to 336 hours post-dose | |
Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as any AE that began or worsened on or after the first dose of treatment until the end of study (EOS) or early termination (ET). An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Day 1 up to Day 15 |
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