At a glance
ClinicalIndex Comparison Record- ✓Age 18-45 years at consent
- ✓Male or non-pregnant, non-lactating female compliant with contraceptive requirements, or of non-childbearing potential
- ✓Satisfactory medical assessment with no clinically significant abnormal findings on history, physical exam, vitals, ECG, and labs
- ✓BMI 18.5-30.0 kg/m² inclusive
- ✕Any disease or condition affecting absorption, action, or disposition of omeprazole or anagrelide (cardiovascular, renal, liver, gastrointestinal, malignancy)
- ✕History of bone marrow suppression, hypersensitivity to investigational product, or adverse hematologic reactions to any drug
- ✕History of symptomatic or clinically meaningful orthostatic hypotension, syncope, or uncontrolled hypertension (SBP ≥140 or DBP ≥90 mmHg)
- ✕History of seizure disorder or cardiac abnormalities (structural abnormalities, syncope, conduction problems, prolonged QTc)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating SPD422 and Omeprazole for Healthy Volunteers. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Participants will receive 1 mg of SPD422 (2\*0.5 mg) capsule orally on Day 1 and 8 in fasted state.
Participants will receive 40 mg of Omeprazole orally once daily on Days 2 - 8.