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Phase 1 Completed N=20 Treatment

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

Healthy Volunteers
Source: ClinicalTrials.gov NCT03866434 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Anagrelide (SPD422) — 5.028; 3.180 nanogram per milliliter (ng/mL)

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Maximum Observed Plasma Concentration (Cmax) of Anagrelide (SPD422)
5.028; 3.180
PRIMARY
Maximum Observed Plasma Concentration (Cmax) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide)
10.30; 8.341
PRIMARY
Area Under the Concentration Versus Time Curve From Zero to Last Time Point (AUC[0-t]) of Anagrelide (SPD422) in Plasma
13.25; 9.683
PRIMARY
Area Under the Concentration Versus Time Curve From Zero to Last Time Point (AUC[0-t]) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) in Plasma
39.51; 33.14
PRIMARY
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Anagrelide (SPD422) in Plasma
13.54; 10.27
PRIMARY
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) in Plasma
40.85; 35.51
SECONDARY
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
9; 0

Eligibility Criteria

Inclusion Criteria

  • Participants who has given, personally signed, and dated informed consent to participate in the study, in accordance with the International Conference on Harmonization Good Clinical Practice Guideline E6 (1996) and applicable regulations, before completing any study-related procedures.
  • Age 18-45 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period. This inclusion criterion will be assessed only at the Screening Visit.
  • Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential. A female of non-childbearing potential (defined as a female who is post-menopausal [amenorrhea for at least 12 consecutive months], has had a hysterectomy, bilateral tubal ligation, bilateral oophorectomy or bilateral salpingectomy.
  • Satisfactory medical assessment with no clinically significant or relevant abnormal findings as determined by medical/surgical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluation (hematology, biochemistry, thyroid function, and urinalysis) that are likely to interfere with the participant's participation or ability to complete the study as assessed by the investigator.
  • An understanding, ability, and willingness to fully comply with study procedures and restrictions.
  • Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter (kg/m^2) inclusive; assessed only at the screening visit.
  • Able to swallow (multiple capsules or tablets at 1 time or consecutively at 1 time) all investigational product.
  • Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion Criteria

  • Current or recurrent disease or conditions (example: cardiovascular, renal, liver, gastrointestinal, malignancy or other conditions) that could affect the absorption, action, or disposition of either omeprazole or anagrelide or its metabolites, or could affect clinical assessments or clinical laboratory evaluations.
  • Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
  • Significant illness, as judged by the investigator, within the 2 weeks of administration of the first dose of investigational product.
  • Use of any medication (including prescription, over-the-counter, herbal, multivitamin, oral contraceptives and other hormonal contraceptive treatments, or homeopathic preparations) within the 30 days prior to the first dose of study drug or during the study through Day 9 (occasional use of acetaminophen is allowed).
  • Treatment with any known hepatic and/or P450 enzyme-altering agents, including CYP1A2 inducers or inhibitors within 30 days prior to the first dose of investigational product. This includes: Strong inhibitor- ciprofloxacin, enoxacin, fluvoxamine, and zafirlukast; Moderate inhibitor- methoxsalen, mexiletine, and oral contraceptives; Moderate inducer- phenytoin, rifampin, ritonavir, smoking, teriflunomide; Inducer- lansoprazole
  • A history of any of the following medical conditions:
  • History of previous bone marrow suppression.
  • History of hypersensitivity to the investigational product.
  • History of adverse hematologic reaction, (such as neutropenia, thrombocytopenia, anemia) to any drug.
  • History of symptomatic or clinically meaningful orthostatic hypotension or syncope, as assessed by the investigator.
  • History of controlled or uncontrolled hypertension or a systolic blood pressure greater than or equal to (>=) 140 millimeters of mercury (mmHg) or diastolic blood pressure >= 90 mmHg at the Screening Visit or Day -1.
  • Participant has any history of seizure disorder.

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View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03866434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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