Clinical Study of AK159 in Healthy Postmenopausal Women
Information source: Asahi Kasei Pharma Corporation
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
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
Summary
The objective of this study is to investigate the pharmacokinetics, safety, and tolerability
of AK159 administered to healthy postmenopausal women.
Clinical Details
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 teriparatidePeak 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 administrationResidual 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.
Eligibility
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;
Locations and Contacts
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
Additional Information
Starting date: March 2012
Last updated: March 12, 2012
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