Clinical trial NCT01384188: A Study to Investigate the Effects of Food and Morning Versus Evening on Single and Multiple Doses of ONO-5334 in Healthy Post Menopausal Women
Official title: A Two-part, Crossover Study to Investigate the Effects of Morning Versus Evening Dosing and Food Interaction on the Pharmacodynamics and Pharmacokinetics of Single and Multiple Doses of ONO-5334 in Healthy Post Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Post Menopausal Women
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2011-06-28
Enrollment: 25
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will investigate the effects on pharmacodynamics and pharmacokinetics of food and morning versus evening on single and multiple doses of ONO-5334 in healthy post menopausal women.

Detailed description: This study consists of 2 parts. Part 1; The study will investigate the effects of morning versus evening dosing on the pharmacodynamics of multiple doses of 150 mg of ONO-5334 in healthy post menopausal women. The study design will be single-blind and 16 subjects will be enrolled. Part 2; The study will investigate the effects of food on the pharmacokinetics of a single dose of 150mg of ONO-5334 in healthy post menopausal women. 12 subjects will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Healthy caucasian women aged between 55 to 75 years inclusive
* Subjects weighing at least 50 kg with mass index between 19 to 30 kg/m2 inclusive
* Subjects who have been amenorrhoeic for at least 5 years.
* Subjects who are confirmed at Screening Visit to have oestradiol and follicle stimulating hormone (FSH) levels consistent with menopause

Exclusion Criteria:

* Subjects who have a clinically relevant history or presence of any clinically significant disease or disorder
* Subjects who have a clinically relevant history of insomnia or sleep disorders

Primary outcomes:
measure: Part 1: Compare pharmacodynamic effect (i.e. urine CTX) of morning versus evening multiple dosing of ONO-5334
timeFrame: end of treatment (5 days)
measure: Part 2: Compare the effects of food on the pharmacodynamics (i.e., AUC, Cmax) of a single dose of ONO-5334
timeFrame: end of day 1
Secondary outcomes:
measure: Safety and tolerability of single or multiple dose of ONO-5334 in healthy post menopausal women
timeFrame: up to the day after the last dose (Part 1: 5 day multiple doses; Part 2: single dose)
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Guildford Clinical Site
state: Surrey
city: London
country: United Kingdom
facility: London Clinical Site
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma UK LTD
role: STUDY_DIRECTOR
References:
citation: Eastell R, Dijk DJ, Small M, Greenwood A, Sharpe J, Yamada H, Yuba M, Tanimoto M, Deacon S. Morning vs evening dosing of the cathepsin K inhibitor ONO-5334: effects on bone resorption in postmenopausal women in a randomized, phase 1 trial. Osteoporos Int. 2016 Jan;27(1):309-18. doi: 10.1007/s00198-015-3342-4. Epub 2015 Oct 7.