A Phase I Study of AK159 in Healthy Postmenopausal Women

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935479
• Other study ID #: AK159 I-4
• Status: Completed
• Phase: Phase 1
• First received: August 29, 2013
• Last updated: February 13, 2017
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: September 2013
• Source: Asahi Kasei Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• 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

• 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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• AK159
transdermal administration of teriparatide acetate
• MN-10-T
subcutaneous administration of teriparatide acetate
• Placebo
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
Other	Residual teriparatide in the patch after application		up to 6 weeks after the initial administration
Primary	Area under the plasma concentration versus time curve (AUC) of teriparatide		up to 6 hours after single and repeated administration
Primary	Peak Plasma Concentration (Cmax) of teriparatide		up to 6 hours after single and repeated administration
Primary	Number of subjects with adverse events and Incidence of adverse events		up to 7 weeks after the initial administration
Primary	Change in bone turnover markers from baseline		up to 7 weeks after the initial administration
Secondary	Visual assessment of the application site		up to 7 weeks after the initial administration