Single-center, 2-arm Interventional Study to Determine the Association between the Gut Microbiome and the Pharmacokinetic Profile of Palbociclib in Healthy Female Volunteers.
- Conditions
- CancerCancer - Any cancer
- Registration Number
- ACTRN12623000821695
- Lead Sponsor
- BioCorteX Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 20
1.Must have given written informed consent, before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2.Healthy female, aged between 18 and 65 years, inclusive at screening.
3.Body mass index (BMI) of 18 to 32 kg/m2, inclusive.
4.Participant is medically healthy (in the opinion of the PI), as determined by pre-study medical history and without clinically significant abnormalities including:
a.Physical examination without any additional clinically relevant findings
b.Systolic blood pressure in the range of 90 to 140 mmHg and diastolic blood pressure in the range of 40 to 90 mmHg after 5 minutes in supine position.
c.Heart rate in the range of 40 to 100 beats/minute after 5 minutes rest in supine position.
d.Body temperature (tympanic), between 35.5°C and 37.7°C.
e.Electrocardiogram (ECG) without clinically significant abnormal including QT interval corrected for Fredericia (QTcF) between 350 to 470 msec.
Note: The above assessments may be repeated, if abnormal values were recorded in the first instance, at the discretion of the Investigator (or delegate).
5.Participant is willing to refrain from consuming food or beverages containing caffeine and/or xanthene products, within 24 hours prior to check-in on Day -1.
6.Participants must be of non-child-bearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or, if of child-bearing potential:
a.Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on Day -1.
b.Must agree not to donate ova or attempt to become pregnant from the time of signing consent until at least 1 month after the last dose of study drug.
c.If not exclusively in a same-sex relationship, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception from one month prior to dose administration until at least 1 month after the last dose of study drug.
Women who have been surgically sterilised through tubal ligation are permitted to participate, if they agree to use an additional barrier method of contraception from one month prior to the first dose of study drug, until at least 1 month after the last dose of study drug.
7.Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures.
8.Willing and able to perform pre-dose and post-dose stool sample collection within the designated timeframe
9.Agreement to have their anonymized data stored in the cloud for up to 15 years after the conclusion of the study.
10.Agreement to have anonymised data incorporated into the BioCorteX proprietary platform for future predictive purposes.
1.Hypersensitivity or other clinically significant reaction to the study drug or its active ingredients.
2.History of any clinically significant disorder, including cardiovascular, hematologic, pulmonary, hepatic, renal, gastrointestinal, connective tissue disease, uncontrolled endocrine/metabolic, oncologic (within the last 5 years), neurologic, and psychiatric diseases, or any disorder that may prevent the successful completion of the study or influence the absorption, distribution, metabolism, excretion, or action of the study drug. Participants with fully resolved childhood asthma with no adult reoccurrence and participants who have undergone cholecystectomy may be included at the discretion of the PI.
3.Absolute neutrophil count <2000 /mm3
4.Platelet count < 150,000 /mm3
5.Antibiotic usage with 30 days prior to screening
6.Concurrent enrolment in another clinical study, or dosed in another clinical study within 30 days or 5 half-lives (whichever is longer) prior to screening.
7.Regular consumption of >14 standard alcoholic drinks/week where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc/Vol], 100 mL wine [12% Alc/Vol], 30 mL spirit [40% Alc/Vol]).
8.Positive alcohol breath or urine test at Screening or upon admission to the clinic on Day -1.
9.Positive urine drugs of abuse test at Screening or upon admission to the clinic on Day -1.
10.Use of tobacco products or nicotine-containing products (including smoking cessation aids such as gum or patches), within 30 days prior to screening, and/or a positive urine cotinine test at Screening or upon admission to the clinic on Day -1.
11.Participant is breastfeeding, or pregnant, or planning to breastfeed or become pregnant during the study.
12.Known substance abuse or medical, psychological, or social conditions that, in the opinion of the PI (or delegate), may interfere with the participants inclusion in the clinical study or evaluation of the clinical study results.
13.Use of any prescription or over-the-counter medication (including herbal products, diet aids, probiotics and hormone supplements) within 30 days or 5 half-lives of the medication (whichever is longer) prior to dosing with study drug and throughout the study period, with the exception of hormonal contraceptives.
14.Positive Hepatitis B surface antigen (HBsAg), Hepatitis C (HepC) virus antibody, or human immunodeficiency (HIV) antibody tests.
15.Participant has donated blood or blood products within 30 days prior to screening.
16.Any other condition or prior therapy that in the opinion of the Investigator (or delegate) would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
17.Unable to provide pre-dose stool sample between Day -3 and predose on Day 1.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method