Clinical Study of AK159 in Healthy Postmenopausal Women

Condition(s) targeted: Osteoporosis

Intervention: AK159 (Drug); MN-10-T (Drug); Placebo (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Asahi Kasei Pharma Corporation

Overall contact:
Asahi Kasei Pharma Corporation, Email: ct-info@om.asahi-kasei.co.jp

The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome:

Area under the plasma concentration versus time curve (AUC) of teriparatide

Peak Plasma Concentration (Cmax) of teriparatide

Number of Participants with Adverse Events, Vital signs, ECG parameters, and 24-hour ECG holter recording (for Part 2 of the study).

Secondary outcome:

Change from Baseline in bone turnover markers within 24 hrs at each administration

Residual teriparatide in the patch after application

Detailed description: This study consists of Part 1 and Part 2. Part 1 will be conducted according to a single-centre, randomized, single-dose, 3-period, 5-treatment alternating crossover design in two groups of healthy post-menopausal women The pharmacokinetics, safety, and tolerability of a single dose of AK159 (4 levels) will be investigated versus teriparatide acetate for injection as a control. Part 2 will be conducted according to a multiple-centre, randomized, double-blind, placebo-controlled, repeated dose parallel design of healthy post-menopausal women The pharmacokinetics, safety, and tolerability of AK159 (4 levels) for 8 weeks will be investigated versus teriparatide acetate for injection and placebo as controls. Pharmacokinetics, safety, and tolerability following long-term application will also be investigated.

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Female.

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;

Asahi Kasei Pharma Corporation, Email: ct-info@om.asahi-kasei.co.jp

Fukuoka, Japan; Recruiting

Kumamoto, Japan; Not yet recruiting

Tokyo, Japan; Not yet recruiting

Starting date: March 2012
Last updated: March 12, 2012