Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.

• Status: Completed
• Trial end date: 2020-11-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alexion Pharmaceuticals
• Treatments: Celecoxib; Choline; Tetrathiomolybdate

Criteria

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.