{'fraction_non_alphanumeric': 0.03253588516746411, 'fraction_numerical': 0.031578947368421054, 'mean_word_length': 6.164383561643835, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
Multiple‐Dose, Safety, Pharmacokinetics, and Pharmacodynamics of a New Selective Estrogen Receptor Modulator, ERA‐923, in Healthy Postmenopausal Women

ERA‐923 is a new selective estrogen receptor modulator under clinical investigation for use in tamoxifen refractory metastatic breast cancer. This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of once‐daily oral ERA‐923 (10–200 mg) for 28 days in healthy postmenopausal females. ERA‐923 was well tolerated, and adverse events were mild and reversible. No clinically significant changes in laboratory values were found with ERA‐923 versus placebo. ERA‐923 appeared to undergo extensive metabolism and enterohepatic recirculation. In addition, pharmacokinetic analysis showed that a high‐fat breakfast increased the extent of absorption. ERA‐923‐dosed subjects had no uterine or ovarian changes when evaluated with transvaginal ultrasound and compared to placebo subjects. Overall, ERA‐923 was safe and well tolerated in postmenopausal women dosed for 28 days.