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 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.
Interventions
Sponsors
Asahi Kasei Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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; 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax) of teriparatide | up to 6 hours after single and repeated administration |
| Area under the plasma concentration versus time curve (AUC) 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
| Measure | Time frame |
|---|---|
| Change from Baseline in bone turnover markers within 24 hrs at each administration | — |
| Residual teriparatide in the patch after application | — |
Countries
Japan
Outcome results
None listed