Clinical Study of AK159 in Healthy Postmenopausal Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Asahi Kasei Pharma Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01551602
First received: March 1, 2012
Last updated: March 12, 2012
Last verified: January 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014