Clinical Study of AK159 in Healthy Postmenopausal Women

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

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: AK159; Drug: MN-10-T; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
  • Kumamoto, Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure
Change from Baseline in bone turnover markers within 24 hrs at each administration
Residual teriparatide in the patch after application

Collaborators and Investigators

• Sponsor: Asahi Kasei Pharma Corporation

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 12, 2012
• First Posted (ESTIMATE): March 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 25, 2016
• Last Update Submitted That Met QC Criteria: July 21, 2016
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: AK159; teriparatide acetate
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: AK159 I-1