Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315205
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-11
Brief Title:
Evaluation of the Pharmacokinetics Safety and Tolerability of IM Letrozole LEBE in Healthy Post-menopausal Women
Sponsor:
Rovi Pharmaceuticals Laboratories
Organization:
Rovi Pharmaceuticals Laboratories
Study Overview
Official Title:
A Phase I Open Label Dose Escalation Study to Evaluate the Pharmacokinetics Safety and Tolerability of Single Intramuscular Injections of Letrozole LEBE at Different Strengths in Voluntary Healthy Post-Menopausal Women
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEILA-1
Brief 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 25 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 weightBMI 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 drugs PK and safety profile over the planned dose range No formal sample size calculation was made for this study
The sample size was estimated based on a minimum number necessary to obtain a preliminary assessment regarding the drugs PK and safety profile over the planned dose range No formal sample size calculation was made for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-503948-13 | EUDRACT_NUMBER | None | None |