NCT03401320

Evaluation of IM Letrozole ISM® Pharmacokinetics, Safety, and Tolerability in Healthy Post-menopausal Women (LISA-1)

A Phase I, Open Label, Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Intramuscular Injections of Letrozole ISM® at Different Strengths in Voluntary Healthy Post Menopausal Women (LISA-1)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Rovi Pharmaceuticals Laboratories · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, open label, dose escalation study designed to evaluate the pharmacokinetics, safety, and tolerability of single intramuscular injections of Letrozole ISM® at different strengths in voluntary healthy post menopausal women

Detailed description

The objective of this study is to assess the pharmacokinetic profile of a single ascending doses of Letrozole ISM® (Rovi), and secondly, to evaluate safety and tolerability of single ascending doses of Letrozole ISM, measure estrogen levels, and characterize oral letrozole pharmacokinetic profile to be used in subsequent comparison to Letrozole ISM. The study will be carried out in healthy post-menopausal women who satisfy inclusion and exclusion criteria. The study consists of 3 treatment periods (TP) (TP1, TP2 and TP3) preceding by 2 Screening Periods (one for TP1 and one for TP3). In TP1, each subject will sequentially receive 1 dose daily of oral Femara (EU sourced) over a period of 14 days followed by a single intramuscular (IM) dose of Letrozole ISM (after a washout period) in TP2. Ascending doses of Letrozole ISM will be given sequentially to four Cohorts (1, 2, 3, and 4) \[NOTE: Cohorts 3 and 4 were not finally performed because the Safety Review Committee considered it was not necessary for the achieving the objectives of the study\] . All subjects who will finalize TP2 and fulfil the eligibility criteria will be offered to participate in TP3. The purpose is to have, at least, a minimum of 12 subjects receiving one oral daily dose of Femara (US sourced) 2.5 mg QD for a period of 14 days, to provide a complete pharmacokinetic (PK)/pharmacodynamic (PD) face-to-face comparison.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Letrozole ISM	2.5 mg Femara + single IM injection of 50-400 mg Letrozole ISM

Timeline

• Start date: 2017-11-06
• Primary completion: 2024-05-17
• Completion: 2024-05-17
• First posted: 2018-01-17
• Last updated: 2024-12-04

Locations

1 site across 1 country: Czechia