Clinical trial NCT01935479: A Phase I Study of AK159 in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Keywords: AK159, teriparatide acetate
Lead sponsor: Asahi Kasei Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2013-09-05
Enrollment: 170
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of teriparatide
timeFrame: up to 6 hours after single and repeated administration
measure: Peak Plasma Concentration (Cmax) of teriparatide
timeFrame: up to 6 hours after single and repeated administration
measure: Number of subjects with adverse events and Incidence of adverse events
timeFrame: up to 7 weeks after the initial administration
measure: Change in bone turnover markers from baseline
timeFrame: up to 7 weeks after the initial administration
Secondary outcomes:
measure: Visual assessment of the application site
timeFrame: up to 7 weeks after the initial administration
Other outcomes:
measure: Residual teriparatide in the patch after application
timeFrame: up to 6 weeks after the initial administration
Locations:
city: Fukuoka
country: Japan
city: Kumamoto
country: Japan
city: Sumida
country: Japan
Study officials:
References: