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

A Single-center, Randomized, Open-label, Three-period Crossover Study to Investigate the Bioequivalence of Alpelisib Granule and Film-coated Tablet Formulation, and the Food Effect of Alpelisib Granule Formulation in Adult Healthy Volunteers

ClinicalTrials.gov Identifier: NCT05195892

Novartis Reference Number: CBYL719F12101

Last Update: May 02, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Healthy Volunteers
Phase 
Phase 1
Overall status 
Recruiting
Start date 
Feb 03, 2022
Completion date 
May 31, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Treatment A
Single oral dose of alpelisib film-coated tablet at 50 mg in fed state
Drug
Treatment B
Single oral dose of alpelisib granule at 50 mg in fed state
Drug
Treatment C
Single oral dose of alpelisib granule at 50 mg in fasted state

Eligibility 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

Study Locations

United Kingdom
Novartis Investigative Site
Recruiting
Belfast, BT9 6AD
Northern Ireland
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]