Clinical Study of AK159 in Healthy Postmenopausal Women

Asahi Kasei Pharma Corporation132 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

132

Conditions

Osteoporosis

Interventions

AK159DRUG

transdermal administration of teriparatide acetate

MN-10-TDRUG

subcutaneous administration of teriparatide acetate

PlaceboDRUG

Multiple administration of placebo AK159

Eligibility

Sex: FEMALEMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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;

Locations (3)

Unnamed facility

Fukuoka, Japan

Unnamed facility

Kumamoto, Japan

Unnamed facility

Tokyo, Japan

Outcomes

Primary Outcomes

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

Time frame: up to 6 hours after single and repeated administration

Peak Plasma Concentration (Cmax) of teriparatide

Time frame: 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).

Time frame: up to 24 hours after single and repeated administration

Secondary Outcomes

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

Residual teriparatide in the patch after application

Data from ClinicalTrials.gov

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