Clinical Study of AK159 in Healthy Postmenopausal Women
- Registration Number
- NCT01551602
- Lead Sponsor
- Asahi Kasei Pharma Corporation
- Brief Summary
The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.
- Detailed Description
This study consists of Part 1 and Part 2. \<Part 1\> 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\> 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 132
- 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.
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AK159 SD 1 AK159 Single administration of AK159 dose level 1 AK159 SD 2 AK159 Single administration of AK159 dose level 2 MN-10-T SD MN-10-T Single administration of MN-10-T AK159 MD 1 AK159 Multiple administration of AK159 dose level 1 AK159 SD 3 AK159 Single administration of AK159 dose level 3 AK159 MD 2 AK159 Multiple administration of AK159 dose level 2 AK159 MD 3 AK159 Multiple administration of AK159 dose level 3 AK159 MD 4 AK159 Multiple administration of AK159 dose level 4 MN-10-T MD MN-10-T Multiple administration of MN-10-T Placebo MD Placebo Multiple administration of placebo AK159 AK159 SD 4 AK159 Single administration of AK159 dose level 4
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) of teriparatide up to 6 hours after single and repeated administration Peak Plasma Concentration (Cmax) of teriparatide up to 6 hours after single and repeated administration Number of Participants with Adverse Events, Vital signs, ECG parameters, and 24-hour ECG holter recording (for Part 2 of the study). up to 24 hours after single and repeated administration
- Secondary Outcome Measures
Name Time Method Change from Baseline in bone turnover markers within 24 hrs at each administration Residual teriparatide in the patch after application