A phase 1 randomized, double-blind, placebo-controlled, maximum tolerated dose escalation, safety, tolerability and pharmacokinetic adaptive study of RAD1901 administered to healthy postmenopausal wome

Completed

• Conditions: brain metastasis; breast cancer; 10027656; 10006232

• Registration Number: NL-OMON41865
• Lead Sponsor: Radius Health, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

healthy post-menopausal female subjects
40-75 yrs, inclusive
BMI: 18.0 - 30.0 kg/m2, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the maximum tolerated dose (MTD), safety, tolerability and<br /><br>pharmacokinetics (PK) of RAD1901 administered orally to healthy postmenopausal<br /><br>women</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine brain-penetration and occupancy of estrogen receptor * (ER*) by<br /><br>RAD1901<br /><br>To determine the concentration of RAD1901 in cerebrospinal fluid (CSF)</p><br>