A Phase I Study of AK159 in Healthy Postmenopausal Women

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Drug: AK159; Drug: MN-10-T; Drug: Placebo

• Registration Number: NCT01935479
• Lead Sponsor: Asahi Kasei Pharma Corporation

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 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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-29
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-02
• Study First Posted: 2013-09-05
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK159 MD 1	AK159	Multiple administration of AK159 dose level 1
AK159 MD 4	AK159	Multiple administration of AK159 dose level 4
AK159 SD 1	AK159	Single administration of AK159 dose level 1
AK159 SD 2	AK159	Single administration of AK159 dose level 2
AK159 SD 3	AK159	Single administration of AK159 dose level 3
MN-10-T MD	MN-10-T	Multiple administration of MN-10-T
Placebo MD	Placebo	Multiple administration of placebo AK159
MN-10-T SD	MN-10-T	Single administration of teriparatide acetate
AK159 SD 4	AK159	Single administration of AK159 dose level 4
AK159 MD 3	AK159	Multiple administration of AK159 dose level 3
AK159 MD 2	AK159	Multiple administration of AK159 dose level 2

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of teriparatide	up to 6 hours after single and repeated administration
Number of subjects with adverse events and Incidence of adverse events	up to 7 weeks after the initial administration
Peak Plasma Concentration (Cmax) of teriparatide	up to 6 hours after single and repeated administration
Change in bone turnover markers from baseline	up to 7 weeks after the initial administration

Secondary Outcome Measures

Name	Time	Method
Visual assessment of the application site	up to 7 weeks after the initial administration