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Clinical Study of AK159 in Healthy Postmenopausal Women | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Clinical Study of AK159 in Healthy Postmenopausal Women

NCT01551602•Asahi Kasei Pharma Corporation

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.

Eligibility

Age

45 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

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
+2 more criteria

Locations (3)

Fukuoka, Japan

Kumamoto, Japan

Tokyo, Japan

Key Dates

Start Date

March 1, 2012

Primary Completion Date

September 1, 2012

Completion Date

October 1, 2012

Last Updated

July 25, 2016

Enrollment

132

ACTUAL participants

Conditions

Osteoporosis

Interventions

AK159

DRUG

MN-10-T

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 25, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study of AK159 in Healthy Postmenopausal Women

Inclusion Criteria

Exclusion Criteria

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