A Phase I Study of AK159 in Healthy Postmenopausal Women

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: AK159; Drug: MN-10-T; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
  • Kumamoto, Japan
  • Sumida, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK159 SD 1; Single administration of AK159 dose level 1	Drug: AK159; transdermal administration of teriparatide acetate
Experimental: AK159 SD 2; Single administration of AK159 dose level 2	Drug: AK159; transdermal administration of teriparatide acetate
Experimental: AK159 SD 3; Single administration of AK159 dose level 3	Drug: AK159; transdermal administration of teriparatide acetate
Experimental: AK159 SD 4; Single administration of AK159 dose level 4	Drug: AK159; transdermal administration of teriparatide acetate
Active Comparator: MN-10-T SD; Single administration of teriparatide acetate	Drug: MN-10-T; subcutaneous administration of teriparatide acetate
Experimental: AK159 MD 1; Multiple administration of AK159 dose level 1	Drug: AK159; transdermal administration of teriparatide acetate
Experimental: AK159 MD 2; Multiple administration of AK159 dose level 2	Drug: AK159; transdermal administration of teriparatide acetate
Experimental: AK159 MD 3; Multiple administration of AK159 dose level 3	Drug: AK159; transdermal administration of teriparatide acetate
Experimental: AK159 MD 4; Multiple administration of AK159 dose level 4	Drug: AK159; transdermal administration of teriparatide acetate
Active Comparator: MN-10-T MD; Multiple administration of MN-10-T	Drug: MN-10-T; subcutaneous administration of teriparatide acetate
Placebo Comparator: Placebo MD; Multiple administration of placebo AK159	Drug: Placebo; Placebo AK159

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration versus time curve (AUC) of teriparatide	up to 6 hours after single and repeated administration
Peak Plasma Concentration (Cmax) 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
Change in bone turnover markers from baseline	up to 7 weeks after the initial administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Visual assessment of the application site	up to 7 weeks after the initial administration

Other Outcome Measures

Outcome Measure	Time Frame
Residual teriparatide in the patch after application	up to 6 weeks after the initial administration

Collaborators and Investigators

• Sponsor: Asahi Kasei Pharma Corporation

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: August 29, 2013
• First Submitted That Met QC Criteria: September 2, 2013
• First Posted (Estimate): September 5, 2013

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 13, 2017
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: AK159, teriparatide acetate
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: AK159 I-4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No