This is a randomised, double-blind, placebo-controlled, Phase I/Ib study which will assess the safety, tolerability, food effect, pharmacokinetics and pharmacodynamics of FOR-6219, a hydroxysteroid (17B) dehydrogenase (HSD17B1) inhibitor. The study will be performed in three parts: (I) Single ascending doses (SAD) in healthy post-menopausal women; (II) multiple ascending doses (MAD) in post-menopausal women; (III) multiple ascending doses in healthy pre-menopausal women.
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Safety and tolerability as measured by the incidence of treatment-emergent adverse events (TEAEs).
Timeframe: Throughout the study until the follow-up visit, i.e. 7 days after the last dose in Parts I and II and until day 35 in Part III.
Proportion of subjects with clinically significant changes in laboratory safety tests.
Timeframe: Throughout the study until the follow-up visit, i.e. 7 days after the last dose in Parts I and II and until day 35 in Part III.
Proportion of subjects with changes in vital signs (blood pressure, diastolic blood pressure and pulse)
Timeframe: Throughout the study until the follow-up visit, i.e. 7 days after the last dose in Parts I and II and until day 35 in Part III.
Proportion of subjects with ECG changes.
Timeframe: Throughout the study until the follow-up visit, i.e. 7 days after the last dose in Parts I and II and until day 35 in Part III.
Presence of any pathology in transvaginal ultrasound (Part III).
Timeframe: Throughout the study until the day of the last dose (day 14).