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A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet Formulations

NCT04686669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-01-29

No results posted yet for this study

Summary

This is a phase 1, randomised, open-label, three-way, three-period, crossover relative bioavailability study to assess the single-dose pharmacokinetics of FOR-6219 in capsule and tablet formulations in postmenopausal women. The effect of high-fat food on the pharmacokinetics of the tablet formulation will also be evaluated. A total of twelve, post-menopausal women, will be randomised to receive a single oral dose of FOR-6219 in three treatment periods: capsule formulation (fasted); tablet formulation (fed); tablet formulation (fasted)

Conditions

  • Relative Bioavailability

Interventions

DRUG

FOR-6219 capsule formulation

FOR-6219 capsule formulation will be available as a soft gelatine capsule with a single dose of 50 milligrams, administered orally.

DRUG

FOR-6219 tablet formulation

FOR-6219 tablet formulation will be available as a tablet with a single dose of 50 milligrams, administered orally.

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
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2021-01-16
Completion
2021-01-16

Countries

  • United Kingdom

Study Locations

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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 NCT04686669 on ClinicalTrials.gov