Clinical Study of AK159 in Healthy Postmenopausal Women

NCT ID: NCT01551602

Last Updated: 2016-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-10-31

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 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

Study Design

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

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 MN-10-T

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

Multiple administration of placebo AK159

Interventions

AK159

transdermal administration of teriparatide acetate

Intervention Type: DRUG

MN-10-T

subcutaneous administration of teriparatide acetate

Intervention Type: DRUG

Placebo

Multiple administration of 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; and 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
• Systolic blood pressure < 90 mmHg
• QTc exceeds 470 msec in a 12-lead electrocardiography
• 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

Tokyo, , Japan

Countries

Japan

Other Identifiers

AK159 I-1

Identifier Type: -

Identifier Source: org_study_id