NCT03866434

Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of SPD422 (Anagrelide Hydrochloride) in Healthy Adult Participants

A Phase 1, Open-label, Single-sequence, Non-randomized, Crossover, Drug-Drug Interaction Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of SPD422 (Anagrelide Hydrochloride) in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This Phase 1, open-label, single-sequence, non-randomized, multiple-dose, crossover pharmacokinetic study is a single site study in the United States and will be conducted to assess the effect of a CYP1A2 inducer (omeprazole 40 mg once daily \[QD\]) on the pharmacokinetics of anagrelide (1 mg) when administered concurrently in healthy participants.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	SPD422	Participants will receive 1 mg of SPD422 (2\*0.5 mg) capsule orally on Day 1 and 8 in fasted state.
DRUG	Omeprazole	Participants will receive 40 mg of Omeprazole orally once daily on Days 2 - 8.

Timeline

• Start date: 2019-02-26
• Primary completion: 2019-04-10
• Completion: 2019-04-10
• First posted: 2019-03-07
• Last updated: 2021-06-15
• Results posted: 2020-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study