OsteoporosisPhase 1NCT01935479
A Phase I Study of AK159 in Healthy Postmenopausal Women
A Phase 1 study testing AK159 and MN-10-T in people with Osteoporosis, run by Asahi Kasei Therapeutics Corporation at 3 sites in Japan.
Trial summary
The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- AK159 and MN-10-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 3 sitesJapan
- Study dates
- Aug 2013to Feb 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
About this study
The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.
Read the detailed description
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.
- Conditions
- Osteoporosis
- Being tested
- AK159, MN-10-T, Placebo
- Keywords
- AK159, teriparatide acetate
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK159Drug
transdermal administration of teriparatide acetate
MN-10-TDrug
subcutaneous administration of teriparatide acetate
PlaceboDrug
Placebo AK159
| Study group | Role | What they receive |
|---|---|---|
| AK159 SD 1 | Experimental | Single administration of AK159 dose level 1 Receives: Drug: AK159 |
| AK159 SD 2 | Experimental | Single administration of AK159 dose level 2 Receives: Drug: AK159 |
| AK159 SD 3 | Experimental | Single administration of AK159 dose level 3 Receives: Drug: AK159 |
| AK159 SD 4 | Experimental | Single administration of AK159 dose level 4 Receives: Drug: AK159 |
| MN-10-T SD | Active comparator | Single administration of teriparatide acetate Receives: Drug: MN-10-T |
| AK159 MD 1 | Experimental | Multiple administration of AK159 dose level 1 Receives: Drug: AK159 |
| AK159 MD 2 | Experimental | Multiple administration of AK159 dose level 2 Receives: Drug: AK159 |
| AK159 MD 3 | Experimental | Multiple administration of AK159 dose level 3 Receives: Drug: AK159 |
| AK159 MD 4 | Experimental | Multiple administration of AK159 dose level 4 Receives: Drug: AK159 |
| MN-10-T MD | Active comparator | Multiple administration of MN-10-T Receives: Drug: MN-10-T |
| Placebo MD | Placebo comparator | Multiple administration of placebo AK159 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of teriparatide
Measured: up to 6 hours after single and repeated administration
Peak Plasma Concentration (Cmax) of teriparatide
Measured: up to 6 hours after single and repeated administration
Number of subjects with adverse events and Incidence of adverse events
Measured: up to 7 weeks after the initial administration
Change in bone turnover markers from baseline
Measured: up to 7 weeks after the initial administration
Secondary outcomes (1)
Visual assessment of the application site
Measured: up to 7 weeks after the initial administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asahi Kasei Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935479
- Sponsor's protocol ID
- AK159 I-4
- Status last verified
- Sep 2013
- First submitted
- 29 Aug 2013
- Last updated
- 15 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of AK159 in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01935479
- Acronym / sponsor ID
- AK159 I-4
- Conditions
- Osteoporosis
- Keywords
- AK159, teriparatide acetate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Asahi Kasei Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| AK159 SD 1 | Experimental | Drug: AK159Single administration of AK159 dose level 1 |
| AK159 SD 2 | Experimental | Drug: AK159Single administration of AK159 dose level 2 |
| AK159 SD 3 | Experimental | Drug: AK159Single administration of AK159 dose level 3 |
| AK159 SD 4 | Experimental | Drug: AK159Single administration of AK159 dose level 4 |
| MN-10-T SD | Active comparator | Drug: MN-10-TSingle administration of teriparatide acetate |
| AK159 MD 1 | Experimental | Drug: AK159Multiple administration of AK159 dose level 1 |
| AK159 MD 2 | Experimental | Drug: AK159Multiple administration of AK159 dose level 2 |
| AK159 MD 3 | Experimental | Drug: AK159Multiple administration of AK159 dose level 3 |
| AK159 MD 4 | Experimental | Drug: AK159Multiple administration of AK159 dose level 4 |
| MN-10-T MD | Active comparator | Drug: MN-10-TMultiple administration of MN-10-T |
| Placebo MD | Placebo comparator | Drug: PlaceboMultiple administration of placebo AK159 |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK159transdermal administration of teriparatide acetate | Drug | 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-Tsubcutaneous administration of teriparatide acetate | Drug | MN-10-T MD, MN-10-T SD |
| PlaceboPlacebo AK159 | Drug | Placebo MD |
Primary outcome
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
1 secondary outcome
Visual assessment of the application site
Time frame: up to 7 weeks after the initial administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AK159 and MN-10-T in people with Osteoporosis, run by Asahi Kasei Therapeutics Corporation at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.