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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41865

Enrollment

Registered

2014-05-15

Start date

2014-06-03

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain metastasis breast cancer

Interventions

During the study the volunteer will receive RAD1901 or placebo with 240 milliliters of water, 30 minutes after the start of a standardized breakfast. After taking the study medication hands and mou

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To determine the maximum tolerated dose (MTD), safety, tolerability and pharmacokinetics (PK) of RAD1901 administered orally to healthy postmenopausal women	—

Secondary

Measure	Time frame
To determine brain-penetration and occupancy of estrogen receptor * (ER*) by RAD1901 To determine the concentration of RAD1901 in cerebrospinal fluid (CSF)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)