A Study to Evaluate Food Effect on ONO-5920/YM529 Intermittent Formulation

Astellas

Status and phase: Completed; Phase 1

Conditions: Osteoporosis; Bone Diseases; Osteoporosis, Postmenopausal

Treatments: Drug: ONO-5920 / YM529

Study type: Interventional

Funder types: Industry

Identifiers

NCT00965978

529-CL-027

Details and patient eligibility

About

The aim of the study is to evaluate the effects of food intake on the plasma concentration profile of YNO-5920/YM529 in post menopausal women.

Enrollment: 48 patients

Sex: Female

Ages: 45 to 81 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Post menopausal women (at least 2 years after menopause)
• Body weight: more than 40.0 Kg and less than 70.0 Kg
• BMI: more than 17.6 and less than 30.0

Exclusion criteria

• Receives investigational drug within 120 day before the study
• Blood donation before the study
• With abnormal laboratory values

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

Low dose group

Experimental group

Description:

Receives low dose of ONO-5920/YM529 with and without food

Treatment:

Drug: ONO-5920 / YM529

High dose group

Experimental group

Description:

Receives high dose of ONO-5920/YM529 with and without food

Treatment:

Drug: ONO-5920 / YM529