Clinical Study of AK159 in Healthy Postmenopausal Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Asahi Kasei Pharma Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01551602
First received: March 1, 2012
Last updated: March 12, 2012
Last verified: January 2012

March 1, 2012
March 12, 2012
March 2012
September 2012   (final data collection date for primary outcome measure)
  • Area under the plasma concentration versus time curve (AUC) of teriparatide [ Time Frame: up to 6 hours after single and repeated administration ] [ Designated as safety issue: No ]
  • Peak Plasma Concentration (Cmax) of teriparatide [ Time Frame: up to 6 hours after single and repeated administration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01551602 on ClinicalTrials.gov Archive Site
  • Change from Baseline in bone turnover markers within 24 hrs at each administration [ Designated as safety issue: No ]
  • Residual teriparatide in the patch after application [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Study of AK159 in Healthy Postmenopausal Women
Not Provided

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Osteoporosis
  • Drug: AK159
    transdermal administration of teriparatide acetate
  • Drug: MN-10-T
    subcutaneous administration of teriparatide acetate
  • Drug: Placebo
    Multiple administration of placebo AK159
  • Experimental: AK159 SD 1
    Single administration of AK159 dose level 1
    Intervention: Drug: AK159
  • Experimental: AK159 SD 2
    Single administration of AK159 dose level 2
    Intervention: Drug: AK159
  • Experimental: AK159 SD 3
    Single administration of AK159 dose level 3
    Intervention: Drug: AK159
  • Experimental: AK159 SD 4
    Single administration of AK159 dose level 4
    Intervention: Drug: AK159
  • Active Comparator: MN-10-T SD
    Single administration of MN-10-T
    Intervention: Drug: MN-10-T
  • Experimental: AK159 MD 1
    Multiple administration of AK159 dose level 1
    Intervention: Drug: AK159
  • Experimental: AK159 MD 2
    Multiple administration of AK159 dose level 2
    Intervention: Drug: AK159
  • Experimental: AK159 MD 3
    Multiple administration of AK159 dose level 3
    Intervention: Drug: AK159
  • Experimental: AK159 MD 4
    Multiple administration of AK159 dose level 4
    Intervention: Drug: AK159
  • Active Comparator: MN-10-T MD
    Multiple administration of MN-10-T
    Intervention: Drug: MN-10-T
  • Placebo Comparator: Placebo MD
    Multiple administration of placebo AK159
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
132
Not Provided
September 2012   (final data collection date for primary outcome measure)

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;
Female
45 Years and older
Yes
Contact: Asahi Kasei Pharma Corporation ct-info@om.asahi-kasei.co.jp
Japan
 
NCT01551602
AK159 I-1
Not Provided
Asahi Kasei Pharma Corporation
Asahi Kasei Pharma Corporation
Not Provided
Not Provided
Asahi Kasei Pharma Corporation
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP