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Trial Title:
Evaluation of the Pharmacokinetics, Safety, and Tolerability of IM Letrozole LEBE in Healthy Post-menopausal Women
NCT ID:
NCT06315205
Condition:
Healthy
Conditions: Official terms:
Letrozole
Conditions: Keywords:
Pharmacokinetics
Safety
Letrozol LEBE
Intramuscular
Breast cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Letrozole LEBE 75 mg
Description:
14 oral doses of Femara 2.5 mg/daily + 28-days (at least) washout period + single IM
injection of Letrozole LEBE 75 mg
Arm group label:
Cohort 1: Letrozol LEBE 75 mg
Intervention type:
Drug
Intervention name:
Letrozole LEBE 150 mg
Description:
14 oral doses of Femara 2.5 mg/daily + 28-days (at least) washout period + single IM
injection of Letrozole LEBE 150 mg
Arm group label:
Cohort 2: Letrozol LEBE 150 mg
Intervention type:
Drug
Intervention name:
Letrozole LEBE 225 mg
Description:
14 oral doses of Femara 2.5 mg/daily + 28-days (at least) washout period + single IM
injection of Letrozole LEBE 225mg
Arm group label:
Cohort 3: Letrozol LEBE 225 mg
Summary:
This is a Phase I, open label, sequential, single ascending dose (SAD) study to evaluate
the pharmacokinetic (PK), safety, and tolerability of Letrozole LEBE in healthy
post-menopausal women.
Detailed description:
The study consists of 1 Screening Period and 2 treatment periods. Evaluation of
eligibility and allocation of subject number to the volunteers will be performed after
Screening. It is planned that subjects will be enrolled in three groups of approximately
30 subjects in each group (Groups 1 to 3), in order to ensure 15 completed subjects per
group in Treatment Period 1 and Treatment Period 2. In Treatment Period 1, each subject
will sequentially receive 1 dose daily of oral Femara (2.5 mg) over a period of 14 days
followed by a single intramuscular (IM) dose of Letrozole LEBE (after a washout period)
in Treatment Period 2. Ascending doses of Letrozole LEBE will be given to Groups 1, 2 and
3. Safety and tolerability will be assessed in all groups by the incidence and severity
of Adverse Events (AEs) and Serious AEs (SAEs), concomitant medication use, vital sign
assessments, clinical laboratory evaluations, 12 lead ECGs, physical examination, and
body weight/BMI. The end of the clinical trial will be the last visit of the last subject
at Day 197 of Treatment Period 2 or any additionally required 4-weeks safety follow up
visits, when plasma levels of letrozole are detectable, whichever occurs later. Those
remaining subjects with detectable plasma levels of letrozole could be followed every 4
weeks.
The sample size was estimated based on a minimum number necessary to obtain a preliminary
assessment regarding the drug's PK and safety profile over the planned dose range. No
formal sample size calculation was made for this study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Healthy post-menopausal women.
- Capable of providing informed consent.
- Weight of ≥50 kg and a BMI ≥19 and ≤39 kg/m2.
- Subjects should be able to communicate with clinic staff.
Exclusion Criteria:
- Subjects who have a history of allergy or hypersensitivity to letrozole or any of
the inactive ingredients.
- Subjects who have a history of galactose intolerance, severe hereditary lactase
deficiency glucose-galactose malabsorption.
- Subjects who have used estrogen or progesterone hormone replacement therapy, thyroid
replacement therapy, oral contraceptives, androgens, luteinizing hormone (LH)
releasing hormone analogs, prolactin inhibitors, or antiandrogens within prior to
Screening.
- Subjects who have used: any medications including St. John's wort or any medications
or products known to be potent or moderate inhibitors of CYP P450 3A4.
- Subjects who have been diagnosed with osteoporosis.
- Subjects who have an abnormality at Screening or prior to first dose that in the
opinion of the investigator increases the risk of participating in the study.
- Subjects who have any clinically significant abnormal physical examination or
laboratory safety findings at screening.
- Subjects who have relevant diseases or clinically significant abnormal relevant
findings at Screening, as determined by medical history, physical examination,
laboratory, ECG, DEXA, and breast and pelvic examination.
- Subjects who have history of any significant chronic disease.
- History of cancer within the past 5 years with the exception of non-melanoma skin
cancer.
- Subjects who have a history of drug-dependence, and recent history of alcoholism or
abuse of alcohol.
- Subjects who have received a drug in research or have participated in other clinical
trials within 90 days, prior to dosing.
- Any other unspecified reason that, in the opinion of the investigator (or designee)
or sponsor, makes the subject unsuitable for enrolment.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Investigational Site number CZ-01
Address:
City:
Praha
Country:
Czechia
Status:
Recruiting
Start date:
July 26, 2023
Completion date:
January 2025
Lead sponsor:
Agency:
Rovi Pharmaceuticals Laboratories
Agency class:
Industry
Source:
Rovi Pharmaceuticals Laboratories
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06315205