NCT01551602

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

July 25, 2016

Status Verified

January 1, 2012

Enrollment Period

6 months

First QC Date

March 1, 2012

Last Update Submit

July 21, 2016

Conditions

Osteoporosis

Keywords

AK159teriparatide acetate

Outcome Measures

Primary Outcomes (3)

  • Area under the plasma concentration versus time curve (AUC) of teriparatide

    up to 6 hours after single and repeated administration

  • Peak Plasma Concentration (Cmax) of teriparatide

    up to 6 hours after single and repeated administration

  • Number of Participants with Adverse Events, Vital signs, ECG parameters, and 24-hour ECG holter recording (for Part 2 of the study).

    up to 24 hours after single and repeated administration

Secondary Outcomes (2)

  • Change from Baseline in bone turnover markers within 24 hrs at each administration

  • Residual teriparatide in the patch after application

Study Arms (11)

AK159 SD 1

EXPERIMENTAL

Single administration of AK159 dose level 1

Drug: AK159

AK159 SD 2

EXPERIMENTAL

Single administration of AK159 dose level 2

Drug: AK159

AK159 SD 3

EXPERIMENTAL

Single administration of AK159 dose level 3

Drug: AK159

AK159 SD 4

EXPERIMENTAL

Single administration of AK159 dose level 4

Drug: AK159

MN-10-T SD

ACTIVE COMPARATOR

Single administration of MN-10-T

Drug: MN-10-T

AK159 MD 1

EXPERIMENTAL

Multiple administration of AK159 dose level 1

Drug: AK159

AK159 MD 2

EXPERIMENTAL

Multiple administration of AK159 dose level 2

Drug: AK159

AK159 MD 3

EXPERIMENTAL

Multiple administration of AK159 dose level 3

Drug: AK159

AK159 MD 4

EXPERIMENTAL

Multiple administration of AK159 dose level 4

Drug: AK159

MN-10-T MD

ACTIVE COMPARATOR

Multiple administration of MN-10-T

Drug: MN-10-T

Placebo MD

PLACEBO COMPARATOR

Multiple administration of placebo AK159

Drug: Placebo

Interventions

AK159DRUG

transdermal administration of teriparatide acetate

AK159 MD 1AK159 MD 2AK159 MD 3AK159 MD 4AK159 SD 1AK159 SD 2AK159 SD 3AK159 SD 4
MN-10-TDRUG

subcutaneous administration of teriparatide acetate

MN-10-T MDMN-10-T SD
PlaceboDRUG

Multiple administration of placebo AK159

Placebo MD

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

July 25, 2016

Record last verified: 2012-01

Locations

JP(3)