Evaluation of the Pharmacokinetics, Safety, and Tolerability of IM Letrozole LEBE in Healthy Post… (NCT06315205) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Evaluation of the Pharmacokinetics, Safety, and Tolerability of IM Letrozole LEBE in Healthy Post-menopausal Women
Czechia90 participantsStarted 2023-07-26
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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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.
* Hi…
What they're measuring
1
λz
Timeframe: Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
2
Cmax
Timeframe: Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
3
Clast
Timeframe: Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
4
tmax
Timeframe: Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
5
tlag
Timeframe: Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
6
t1/2
Timeframe: Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197
7
AUC∞
Timeframe: Following single IM administration of Letrozole LEBE (Treatment Period 2, Day 1) until Day 197