NCT01551602

Clinical Study of AK159 in Healthy Postmenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (actual)
• 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 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.

Conditions

• Osteoporosis

Interventions

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

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-09-01
• Completion: 2012-10-01
• First posted: 2012-03-13
• Last updated: 2016-07-25

Locations

3 sites across 1 country: Japan