A Phase I Study of AK159 in Healthy Postmenopausal Women

NCT ID: NCT01935479

Last Updated: 2017-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-02-28

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.

Conditions

Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

AK159 SD 1

Single administration of AK159 dose level 1

Group Type: EXPERIMENTAL

AK159

Intervention Type: DRUG

transdermal administration of teriparatide acetate

AK159 SD 2

Single administration of AK159 dose level 2

Group Type: EXPERIMENTAL

AK159

Intervention Type: DRUG

transdermal administration of teriparatide acetate

AK159 SD 3

Single administration of AK159 dose level 3

Group Type: EXPERIMENTAL

AK159

Intervention Type: DRUG

transdermal administration of teriparatide acetate

AK159 SD 4

Single administration of AK159 dose level 4

Group Type: EXPERIMENTAL

AK159

Intervention Type: DRUG

transdermal administration of teriparatide acetate

MN-10-T SD

Single administration of teriparatide acetate

Group Type: ACTIVE_COMPARATOR

MN-10-T

Intervention Type: DRUG

subcutaneous administration of teriparatide acetate

AK159 MD 1

Multiple administration of AK159 dose level 1

Group Type: EXPERIMENTAL

AK159

Intervention Type: DRUG

transdermal administration of teriparatide acetate

AK159 MD 2

Multiple administration of AK159 dose level 2

Group Type: EXPERIMENTAL

AK159

Intervention Type: DRUG

transdermal administration of teriparatide acetate

AK159 MD 3

Multiple administration of AK159 dose level 3

Group Type: EXPERIMENTAL

AK159

Intervention Type: DRUG

transdermal administration of teriparatide acetate

AK159 MD 4

Multiple administration of AK159 dose level 4

Group Type: EXPERIMENTAL

AK159

Intervention Type: DRUG

transdermal administration of teriparatide acetate

MN-10-T MD

Multiple administration of MN-10-T

Group Type: ACTIVE_COMPARATOR

MN-10-T

Intervention Type: DRUG

subcutaneous administration of teriparatide acetate

Placebo MD

Multiple administration of placebo AK159

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo AK159

Interventions

AK159

transdermal administration of teriparatide acetate

Intervention Type: DRUG

MN-10-T

subcutaneous administration of teriparatide acetate

Intervention Type: DRUG

Placebo

Placebo AK159

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Asahi Kasei Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fukuoka, , Japan

Kumamoto, , Japan

Sumida City, , Japan

Countries

Japan

Other Identifiers

AK159 I-4

Identifier Type: -

Identifier Source: org_study_id