Investigate Bioequivalence of Alpelisib Granule and Film-coated Tablet Formulation and the Food Effect of Alpelisib Granule Formulation in Adult Healthy Volunteers

• Status: Not yet recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

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 food effect of the granule formulation will be investigated between the fed state and the fasted state.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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