Overview

Clinical Study of AK159 in Healthy Postmenopausal Women

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
Female
Summary
The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Asahi Kasei Pharma Corporation
Treatments:
Teriparatide
Criteria
Inclusion Criteria:

- Healthy postmenopausal ethnic Japanese women; At least 45 years of age at the time
consent is obtained; and Give voluntary consent in writing with a sufficient
understanding of the study.

Exclusion Criteria:

- Clinical abnormality identified in the laboratory tests

- Weight < 40.0 kg

- Body mass index < 17.5 or >=30.5

- History of disease of the kidneys, liver, heart, brain, or other organ that makes them
ineligible as subjects

- Previously received radiation treatment potentially affecting bone

- Systolic blood pressure < 90 mmHg

- QTc exceeds 470 msec in a 12-lead electrocardiography

- Serum calcium level exceeding 10.4 mg/dL

- History of contact dermatitis or skin disease potentially compromising study
evaluation

- Used drugs which impact bone metabolism in the 8-week period preceding investigational
product administration

- Used a bisphosphonate;

- Used a teriparatide product;