Clinical Study of AK159 in Healthy Postmenopausal Women

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551602
• Other study ID #: AK159 I-1
• Status: Completed
• Phase: Phase 1
• First received: March 1, 2012
• Last updated: July 21, 2016
• Start date: March 2012
• Est. completion date: October 2012

Study information

• Verified date: January 2012
• Source: Asahi Kasei Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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;

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• AK159
transdermal administration of teriparatide acetate
• MN-10-T
subcutaneous administration of teriparatide acetate
• Placebo
Multiple administration of placebo AK159

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asahi Kasei Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC) of teriparatide		up to 6 hours after single and repeated administration	No
Primary	Peak Plasma Concentration (Cmax) of teriparatide		up to 6 hours after single and repeated administration	No
Primary	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	Yes
Secondary	Change from Baseline in bone turnover markers within 24 hrs at each administration			No
Secondary	Residual teriparatide in the patch after application			No