Clinical Study of AK159 in Healthy Postmenopausal Women - Full Text View

Purpose

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

Condition	Intervention	Phase
Osteoporosis	Drug: AK159 Drug: MN-10-T Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Teriparatide Teriparatide acetate

U.S. FDA Resources

Further study details as provided by Asahi Kasei Pharma Corporation:

Primary Outcome Measures:

Area under the plasma concentration versus time curve (AUC) of teriparatide [ Time Frame: up to 6 hours after single and repeated administration ] [ Designated as safety issue: No ]
Peak Plasma Concentration (Cmax) of teriparatide [ Time Frame: up to 6 hours after single and repeated administration ] [ Designated as safety issue: No ]
Number of Participants with Adverse Events, Vital signs, ECG parameters, and 24-hour ECG holter recording (for Part 2 of the study). [ Time Frame: up to 24 hours after single and repeated administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from Baseline in bone turnover markers within 24 hrs at each administration [ Designated as safety issue: No ]
Residual teriparatide in the patch after application [ Designated as safety issue: No ]

Estimated Enrollment:	132
Study Start Date:	March 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 MN-10-T	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 Multiple administration of placebo AK159

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

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551602

Contacts

Contact: Asahi Kasei Pharma Corporation

ct-info@om.asahi-kasei.co.jp

Locations

Japan
	Recruiting
Fukuoka, Japan
	Not yet recruiting
Kumamoto, Japan
	Not yet recruiting
Tokyo, Japan

Sponsors and Collaborators

Asahi Kasei Pharma Corporation

More Information

No publications provided

Responsible Party:	Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier:	NCT01551602 History of Changes
Other Study ID Numbers:	AK159 I-1
Study First Received:	March 1, 2012
Last Updated:	March 12, 2012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Asahi Kasei Pharma Corporation:

AK159
teriparatide acetate

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013