NCT01935479

A Phase I Study of AK159 in Healthy Postmenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Asahi Kasei Therapeutics Corporation · Industry
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	AK159	transdermal administration of teriparatide acetate
DRUG	MN-10-T	subcutaneous administration of teriparatide acetate
DRUG	Placebo	Placebo AK159

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-09-05
• Last updated: 2017-02-15

Locations

3 sites across 1 country: Japan