A BA/BE study to evaluate the safety, tolerability of endoxifen in healthy human subjects

Phase 1

Completed

• Registration Number: CTRI/2009/091/000625
• Lead Sponsor: ambda Therapeutic Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Healthy human male or female between 18 - 55 years of age (both inclusive) living in and around Ahmedabad city of western part of India.

Having a Body Mass Index (BMI) between 18.5- 24.9 (both inclusive), calculated as weight in kg / height in m2.

Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, 12-lead ECG and X-ray chest (postero-anterior view) recordings.

Able to comply with study procedures, in the opinion of the Principal Investigator.

Able to give written consent for participation in the trial.

In case of female subjects:

a) They must have been surgically sterile at least for 6 months prior to participation in the trial. Or

b) Those who are of child bearing potential must be using a suitable and effective double barrier contraceptive method or intra uterine devices during the study

Exclusion Criteria

Known hypersensitivity or idiosyncratic reaction to endoxifen, tamoxifen or any related drug.
Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
Ingestion of a medication at any time in 14 days prior to dosing. In any such case subject selection will be at the discretion of the Principal Investigator. Or ingestion of any enzyme inducer or inhibitor drug within 28 days of dosing.
Any history or presence of asthma (including aspirin viii. Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
History of psychiatric disorders.
A history of difficulty with donating blood.
Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the study medicine.
Note: In case the blood loss is ≤ 200 mL; subject may be enrolled 60 days after blood donation.
Testing positive in pregnancy test (females)
Nursing mothers (females)

Study & Design

• Study Type: Interventional
• Study Design: Not specified