Status:
COMPLETED
Investigate Bioequivalence of Alpelisib Granule and Film-coated Tablet Formulation and the Food Effect of Alpelisib Granule Formulation in Adult Healthy Volunteers
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess bioequivalence of the granule formulation of alpelisib as compared to the film-coated tablet formulation in healthy volunteers in the fed state. In addition, the...
Detailed Description
This is a single-center, randomized, open-label, three-period six-sequence crossover study. The study consists of a screening period followed by Periods 1, 2, and 3 and a safety follow-up. Randomizat...
Eligibility Criteria
Inclusion
- Male or female participants 18 and 55 years of age
- Female participants must be postmenopausal or not of child bearing potential.
- Participants must weigh 50 kg - 120 kg and have BMI= 18.0-30.0 kg/m2
- Participants should be in good health as determined by no clinically significant findings from the medical history, physical examination, vital signs, and ECG.
- Participant must have laboratory values (including fasting plasma glucose and HgbA1C) within the reference range at the local laboratory
- At screening, and at baseline visit of each Period, participant has vital signs which are within the protocol defined ranges
Exclusion
- Women of childbearing potential
- Sexually active male participant with partner(s) of women of childbearing potential, UNLESS agree to comply with highly effective contraception AND use a condom
- Participant with
- significant illness, including infections, or hospitalization within the 30 days prior to dosing.
- diabetes mellitus or participants with fasting plasma glucose (FPG) levels \> 100 mg/dL or \>5.55 mmol/L.
- clinically significant risk of developing diabetes mellitus during the study
- Use of:
- tobacco products within 3 months prior to first dosing
- drug or alcohol abuse within 12 months prior to first dose
- alcohol within 48 hours prior to the dosing of each treatment period.
- any prescription or non-prescription, herbal medication, dietary supplements or vitamins during 14 days prior to dosing..
- History of :
- clinically significant hematologic, renal, endocrinologic, pulmonary, cardiovascular, hepatic, or allergic disease, medically documented. including uncontrolled hypertension, interstitial lung disease, or other causes of dyspnea, acute pancreatitis within 1 year of screening or past medical
- chronic pancreatitis.
- cardiac disease
- immunodeficiency diseases
- malignancy of any organ system carcinoma of the skin or in situ cervical cancer), within 5 years,
- erythema multiform (EM), Steven-Johnson-Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN).
- history or presence of
- any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs.
- clinically significant ECG abnormalities or a family prolonged QT-interval syndrome.
- chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV).
- Other inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
February 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05195892
Start Date
February 3 2022
End Date
November 9 2022
Last Update
December 28 2022
Active Locations (1)
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1
Novartis Investigative Site
Belfast, Northern Ireland, United Kingdom, BT9 6AD