A Phase I Study of AK159 in Healthy Postmenopausal Women

NCT01935479 | Completed Phase 1

• 1 other identifier: AK159 I-4
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Osteoporosis

Keywords

AK159, teriparatide acetate

Outcome Measures

Primary Outcomes (4)

• 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 subjects with adverse events and Incidence of adverse events

  up to 7 weeks after the initial administration

• Change in bone turnover markers from baseline

  up to 7 weeks after the initial administration

Secondary Outcomes (1)

• Visual assessment of the application site

  up to 7 weeks after the initial administration

Other Outcomes (1)

• Residual teriparatide in the patch after application

  up to 6 weeks after the initial administration

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 teriparatide acetate

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

AK159 DRUG

transdermal administration of teriparatide acetate

AK159 MD 1; AK159 MD 2; AK159 MD 3; AK159 MD 4; AK159 SD 1; AK159 SD 2; AK159 SD 3; AK159 SD 4

MN-10-T DRUG

subcutaneous administration of teriparatide acetate

MN-10-T MD; MN-10-T SD

Placebo DRUG

Placebo AK159

Placebo MD

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• 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
• 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

Sponsors & Collaborators

• Asahi Kasei Pharma Corporation: lead

Study Sites (3)

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Sumida City, Japan

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 5, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 15, 2017

Record last verified: 2013-09

Locations

JP (3)