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 2017-02-15.
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 two parts: Part 1 and Part 2. The Part 1 is a single-center, randomized, 2-way crossover study that investigates the pharmacokinetics, safety, and tolerability of teriparatide after a single dose of AK159 (5 levels) and estimates the relative bioavailability of AK159 with subcutaneous teriparatide acetate in healthy post-menopausal women.
The Part 2 is a multiple-center, randomized, double-blind, positive- and placebo-controlled, parallel study that compares the pharmacokinetics, bone makers, safety, and tolerability of teriparatide after a weekly doses of AK159 (4 levels) for 6 weeks with placebo and a weekly doses of subcutaneous teriparatide acetate in healthy post-menopausal women.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's planned enrollment of 170 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.
Counted across the registry records on this site, refreshed daily.
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 teriparatide acetate
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
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 subjects with adverse events and Incidence of adverse events
Time frame: up to 7 weeks after the initial administration
Change in bone turnover markers from baseline
Time frame: up to 7 weeks after the initial administration
Visual assessment of the application site
Time frame: up to 7 weeks after the initial administration
Residual teriparatide in the patch after application
Time frame: up to 6 weeks after the initial administration
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Asahi Kasei Pharma Corporation