search
Back to results

A Phase I 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
Asahi Kasei Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoporosis focused on measuring AK159, teriparatide acetate

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy postmenopausal ethnic Japanese women
  • At least 45 years of age at the time consent is obtained
  • 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
  • Clinical abnormality identified in the 12-lead ECGs performed at the study center during the screening period
  • Systolic blood pressure < 90 mmHg
  • 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 teriparatide acetate

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 subjects with adverse events and Incidence of adverse events
Change in bone turnover markers from baseline

Secondary Outcome Measures

Visual assessment of the application site

Full Information

First Posted
August 29, 2013
Last Updated
February 13, 2017
Sponsor
Asahi Kasei Pharma Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01935479
Brief Title
A Phase I Study of AK159 in Healthy Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (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 two parts: Part 1 and Part 2. The Part 1 is a single-center, randomized, 2-way crossover study that investigates the pharmacokinetics, safety, and tolerability of teriparatide after a single dose of AK159 (5 levels) and estimates the relative bioavailability of AK159 with subcutaneous teriparatide acetate in healthy post-menopausal women. The Part 2 is a multiple-center, randomized, double-blind, positive- and placebo-controlled, parallel study that compares the pharmacokinetics, bone makers, safety, and tolerability of teriparatide after a weekly doses of AK159 (4 levels) for 6 weeks with placebo and a weekly doses of subcutaneous teriparatide acetate in healthy post-menopausal women.

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
ParticipantInvestigator
Allocation
Randomized
Enrollment
170 (Anticipated)

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 teriparatide acetate
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
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 subjects with adverse events and Incidence of adverse events
Time Frame
up to 7 weeks after the initial administration
Title
Change in bone turnover markers from baseline
Time Frame
up to 7 weeks after the initial administration
Secondary Outcome Measure Information:
Title
Visual assessment of the application site
Time Frame
up to 7 weeks after the initial administration
Other Pre-specified Outcome Measures:
Title
Residual teriparatide in the patch after application
Time Frame
up to 6 weeks after the initial administration

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 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 Clinical abnormality identified in the 12-lead ECGs performed at the study center during the screening period Systolic blood pressure < 90 mmHg 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
Sumida
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

A Phase I Study of AK159 in Healthy Postmenopausal Women

We'll reach out to this number within 24 hrs