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Evaluation of the Pharmacokinetics, Safety, and Tolerability of IM Letrozole LEBE in Healthy Post-menopausal Women
Evaluation of the Pharmacokinetics, Safety, and Tolerability of IM Letrozole LEBE in Healthy Post-menopausal Women

NCT06315205

CompletedPhase 1

Sponsor: Rovi Pharmaceuticals Laboratories

Conditions: Healthy

Interventions: Letrozole LEBE 75 mg, Letrozole LEBE 150 mg, Letrozole LEBE 225 mg

Countries: Czechia

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.
Locations (1)
  • Prague, Czechia