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A Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics and Pharmacodynamics of FOR-6219

NCT03709420 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2020-11-18

No results posted yet for this study

Summary

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.

Conditions

  • Endometriosis

Interventions

DRUG

Placebo

Placebo capsule to match active drug

DRUG

FOR-6219

FOR-6219 capsule

Sponsors & Collaborators

  • Richmond Pharmacology Limited

    collaborator INDUSTRY

  • Forendo Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Ulrike Lorch, M.D. · Richmond Pharmacology Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-13
Primary Completion
2020-11-11
Completion
2020-11-11

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03709420 on ClinicalTrials.gov