Clinical trial NCT01551602: Clinical 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: 2012-03-13
Enrollment: 132
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 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.

Eligibility 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;

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 Participants with Adverse Events, Vital signs, ECG parameters, and 24-hour ECG holter recording (for Part 2 of the study).
timeFrame: up to 24 hours after single and repeated administration
Secondary outcomes:
measure: Change from Baseline in bone turnover markers within 24 hrs at each administration
measure: Residual teriparatide in the patch after application
Other outcomes:
Locations:
city: Fukuoka
country: Japan
city: Kumamoto
country: Japan
city: Tokyo
country: Japan
Study officials:
References: