A Phase 1 interventional study of AK159 and MN-10-T in Osteoporosis, sponsored by Asahi Kasei Pharma Corporation. Completed at 3 sites in Japan. Open to female participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-25.
Sponsored by Asahi Kasei Pharma Corporation · Phase 1, Interventional, and Basic science
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 132 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Asahi Kasei Pharma Corporation is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Single administration of AK159 dose level 1
Drug: AK159
Single administration of AK159 dose level 2
Drug: AK159
Single administration of AK159 dose level 3
Drug: AK159
Single administration of AK159 dose level 4
Drug: AK159
Single administration of MN-10-T
Drug: MN-10-T
Multiple administration of AK159 dose level 1
Drug: AK159
Multiple administration of AK159 dose level 2
Drug: AK159
Multiple administration of AK159 dose level 3
Drug: AK159
Multiple administration of AK159 dose level 4
Drug: AK159
Multiple administration of MN-10-T
Drug: MN-10-T
Multiple administration of placebo AK159
Drug: Placebo
transdermal administration of teriparatide acetate
subcutaneous administration of teriparatide acetate
Multiple administration of placebo AK159
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
Change from Baseline in bone turnover markers within 24 hrs at each administration
Residual teriparatide in the patch after application
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Asahi Kasei Pharma Corporation