Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04526210
Recruitment Status : Completed
First Posted : August 25, 2020
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE August 19, 2020
First Posted Date  ICMJE August 25, 2020
Last Update Posted Date July 22, 2021
Actual Study Start Date  ICMJE October 21, 2020
Actual Primary Completion Date May 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
  • Maximum Observed Plasma Concentration (Cmax) Of Bupropion With And Without The Coadministration Of ALXN1840 [ Time Frame: Baseline, up to 336 hours post-dose ]
  • 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 [ Time Frame: Baseline, up to 336 hours post-dose ]
  • Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) Of Bupropion With And Without The Coadministration Of ALXN1840 [ Time Frame: Baseline, up to 336 hours post-dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
  • Cmax Of Hydroxybupropion With And Without The Coadministration Of ALXN1840 [ Time Frame: Baseline, up to 336 hours post-dose ]
  • AUCt Of Hydroxybupropion With And Without The Coadministration Of ALXN1840 [ Time Frame: Baseline, up to 336 hours post-dose ]
  • AUCinf Of Hydroxybupropion With And Without The Coadministration Of ALXN1840 [ Time Frame: Baseline, up to 336 hours post-dose ]
  • Cmax Of Molybdenum With Coadministration Of Bupropion [ Time Frame: Baseline, up to 336 hours post-dose ]
  • AUCt Of Molybdenum With Coadministration Of Bupropion [ Time Frame: Baseline, up to 336 hours post-dose ]
  • AUCinf Of Molybdenum With Coadministration Of Bupropion [ Time Frame: Baseline, up to 336 hours post-dose ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

The study is being conducted as a randomized, 2-period, 2-sequence, cross-over study to determine the effect of a single dose of ALXN1840 (perpetrator) on the single-dose bupropion (victim) kinetics in healthy male and female participants.

The study has a Screening Period (Day -28 to Day -2), two 11-day study periods (Day 1 to Day 11) with a minimum of 14 days between doses of bupropion, and an End of Study Visit (Day 15 ± 2 days) after Period 2 dosing. Participants will report to the clinical research unit on the day prior (Day -1) to both dosing periods. All participants will receive 1 treatment in each study period; treatment order will be defined based on randomization: Treatments A and B.

The time between dosing bupropion alone or in combination with ALXN1840 in each treatment sequence will be a minimum of 14 days.

The PK profile of ALXN1840 and bupropion will be determined by blood sampling following single dose administration.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Wilson Disease
Intervention  ICMJE
  • Drug: ALXN1840
    ALXN1840 will be administered orally as a single dose as 4 x 15 mg enteric-coated tablets with 240 milliliters of water (fasting), for a total dose of 60 mg.
    Other Names:
    • WTX101
    • Bis-choline tetrathiomolybdate
    • Tiomolibdate choline
  • Drug: Bupropion Hydrochloride
    Bupropion hydrochloride will be administered orally as a single dose as one 150 milligrams (mg) tablet with 240 milliliters of water (fasting).
    Other Name: Wellbutrin SR 150
Study Arms  ICMJE
  • Experimental: Treatment A
    Participants will receive bupropion.
    Intervention: Drug: Bupropion Hydrochloride
  • Experimental: Treatment B
    Participants will receive bupropion with ALXN1840.
    Interventions:
    • Drug: ALXN1840
    • Drug: Bupropion Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2021)
54
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2020)
38
Actual Study Completion Date  ICMJE May 19, 2021
Actual Primary Completion Date May 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04526210
Other Study ID Numbers  ICMJE ALXN1840-HV-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alexion Pharmaceuticals
Study Sponsor  ICMJE Alexion Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alexion Pharmaceuticals
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP