Back to resultsClinical Study of AK159 in Healthy Postmenopausal Women
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
AK159
MN-10-T
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Osteoporosis focused on measuring AK159, teriparatide acetate
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
AK159 SD 1
AK159 SD 2
AK159 SD 3
AK159 SD 4
MN-10-T SD
AK159 MD 1
AK159 MD 2
AK159 MD 3
AK159 MD 4
MN-10-T MD
Placebo MD
Arm Description
Single administration of AK159 dose level 1
Single administration of AK159 dose level 2
Single administration of AK159 dose level 3
Single administration of AK159 dose level 4
Single administration of MN-10-T
Multiple administration of AK159 dose level 1
Multiple administration of AK159 dose level 2
Multiple administration of AK159 dose level 3
Multiple administration of AK159 dose level 4
Multiple administration of MN-10-T
Multiple administration of placebo AK159
Outcomes
Primary Outcome Measures
Area under the plasma concentration versus time curve (AUC) of teriparatide
Peak Plasma Concentration (Cmax) of teriparatide
Number of Participants with Adverse Events, Vital signs, ECG parameters, and 24-hour ECG holter recording (for Part 2 of the study).
Secondary Outcome Measures
Change from Baseline in bone turnover markers within 24 hrs at each administration
Residual teriparatide in the patch after application
Full Information
NCT ID
NCT01551602
First Posted
March 1, 2012
Last Updated
July 21, 2016
Sponsor
Asahi Kasei Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01551602
Brief Title
Clinical Study of AK159 in Healthy Postmenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asahi Kasei Pharma Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
AK159, teriparatide acetate
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AK159 SD 1
Arm Type
Experimental
Arm Description
Single administration of AK159 dose level 1
Arm Title
AK159 SD 2
Arm Type
Experimental
Arm Description
Single administration of AK159 dose level 2
Arm Title
AK159 SD 3
Arm Type
Experimental
Arm Description
Single administration of AK159 dose level 3
Arm Title
AK159 SD 4
Arm Type
Experimental
Arm Description
Single administration of AK159 dose level 4
Arm Title
MN-10-T SD
Arm Type
Active Comparator
Arm Description
Single administration of MN-10-T
Arm Title
AK159 MD 1
Arm Type
Experimental
Arm Description
Multiple administration of AK159 dose level 1
Arm Title
AK159 MD 2
Arm Type
Experimental
Arm Description
Multiple administration of AK159 dose level 2
Arm Title
AK159 MD 3
Arm Type
Experimental
Arm Description
Multiple administration of AK159 dose level 3
Arm Title
AK159 MD 4
Arm Type
Experimental
Arm Description
Multiple administration of AK159 dose level 4
Arm Title
MN-10-T MD
Arm Type
Active Comparator
Arm Description
Multiple administration of MN-10-T
Arm Title
Placebo MD
Arm Type
Placebo Comparator
Arm Description
Multiple administration of placebo AK159
Intervention Type
Drug
Intervention Name(s)
AK159
Intervention Description
transdermal administration of teriparatide acetate
Intervention Type
Drug
Intervention Name(s)
MN-10-T
Intervention Description
subcutaneous administration of teriparatide acetate
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Multiple administration of placebo AK159
Primary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of teriparatide
Time Frame
up to 6 hours after single and repeated administration
Title
Peak Plasma Concentration (Cmax) of teriparatide
Time Frame
up to 6 hours after single and repeated administration
Title
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
Secondary Outcome Measure Information:
Title
Change from Baseline in bone turnover markers within 24 hrs at each administration
Title
Residual teriparatide in the patch after application
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Facility Information:
City
Fukuoka
Country
Japan
City
Kumamoto
Country
Japan
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of AK159 in Healthy Postmenopausal Women
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