Osteoporosis
Conditions
Keywords
AK159, teriparatide acetate
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 two parts: Part 1 and Part 2. The Part 1 is a single-center, randomized, 2-way crossover study that investigates the pharmacokinetics, safety, and tolerability of teriparatide after a single dose of AK159 (5 levels) and estimates the relative bioavailability of AK159 with subcutaneous teriparatide acetate in healthy post-menopausal women. The Part 2 is a multiple-center, randomized, double-blind, positive- and placebo-controlled, parallel study that compares the pharmacokinetics, bone makers, safety, and tolerability of teriparatide after a weekly doses of AK159 (4 levels) for 6 weeks with placebo and a weekly doses of subcutaneous teriparatide acetate in healthy post-menopausal women.
Interventions
Sponsors
Asahi Kasei Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy postmenopausal ethnic Japanese women * At least 45 years of age at the time consent is obtained * 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 * Clinical abnormality identified in the 12-lead ECGs performed at the study center during the screening period * Systolic blood pressure \< 90 mmHg * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in bone turnover markers from baseline | up to 7 weeks after the initial administration |
| 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 subjects with adverse events and Incidence of adverse events | up to 7 weeks after the initial administration |
Secondary
| Measure | Time frame |
|---|---|
| Visual assessment of the application site | up to 7 weeks after the initial administration |
Other
| Measure | Time frame |
|---|---|
| Residual teriparatide in the patch after application | up to 6 weeks after the initial administration |
Countries
Japan
Outcome results
None listed