Low TestosteronePhase 2NCT02381288
Effects of TAK-448 in Middle-aged and Older Men With Low Testosterone
A Phase 2 study testing TAK-448 in people with Low Testosterone, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6 weeks of subcutaneous (SC) administration of different doses and dosing frequencies of TAK-448 to middle-aged and older men with low ST levels. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Low Testosterone
- What is being tested?
- TAK-448
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2015to 8 Apr 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has total serum testosterone (ST) levels less than 300 ng/dL at Screening.
- Has a body mass index (BMI) between 20.0 and 40.0 kg/m^2, inclusive at Screening.
- A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from the time of signing of informed consent throughout the duration of the study and for 12 weeks after the last dose.
Who cannot join
- Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality that may impact the ability of the participant to participate or potentially confound the study results. Participants will be excluded based on:
- Has a serum creatinine >2.0 milligrams per deciliter (mg/dL) at Screening.
- Is receiving dialysis treatment.
- Has an American Urological Association (AUA)/ International Prostate Symptom Score (I-PSS) score of >19 or serum prostate-specific antigen (PSA) >4 nanogram per milliliter (ng/mL) at Screening.
- Has thyrotropin (TSH) levels less than (<) 0.3 or >7.5 milli-international units per liter (mIU/L) at Screening.
- Has systolic blood pressure >160 millimeter of mercury (mm Hg) or diastolic blood pressure >100 mm Hg (if out of range may be repeated once for eligibility determination) at Screening.
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- Has luteinizing hormone (LH) >9.4 units per liter (U/L) at Screening.
- Is receiving insulin therapy.
- Has a hematocrit <30 percent (%) or >48% at Screening.
- Has a glycosylated hemoglobin (HbA1c) >8.0 at Screening (Cohort 1).
- Has type 2 diabetes mellitus defined as fasting blood glucose >125 mg/dL, glycosylated hemoglobin (HbA1c) >6.2%, or use of antidiabetic medication (Cohort 2 only).
- Has clinical evidence of anatomic or pathological hypothalamic/pituitary/testicular disease, such as (but not limited to) Klinefelter's syndrome, Kallmann's syndrome, systemic infiltrative diseases (hemochromatosis, sarcoidosis, Wilson's disease), or prior pituitary surgery.
- Has used gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, antiandrogens, clomiphene, or other reproductive hormone-related agents within 6 months prior to Screening.
- Has used anabolic therapies (testosterone, dehydroepiandrosterone [DHEA], androstendione, any other androgen, or recombinant human growth hormone) within 1 year of Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Stimulatory Effects of TAK-448, a Kisspeptin Analog, Administered Intermittently in Middle-aged and Older Men With Low Testosterone
The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6 weeks of subcutaneous (SC) administration of different doses and dosing frequencies of TAK-448 to middle-aged and older men with low ST levels.
Read the detailed description
The drug tested in this study is called TAK-448. TAK-448 was tested to define a dose and dose frequency which results in a clinically relevant improvement in ST in middle-aged and older men with low ST levels. This study looked at ST levels in men who took TAK-448.
The study enrolled 17 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the following treatment groups-which remained undisclosed to the participants and study doctor during the study (unless there is an urgent medical need):
- TAK-448 0.1 µg
- TAK-448 0.3 µg
- TAK-448 1.0 µg
- Placebo (dummy inactive injection) - this was a injection that looks like the study drug but has no active ingredient All participants received subcutaneous injection either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
This single-center trial was conducted in the United States. The overall time to participate in this study is up to 56 days. Participants made daily visits to the clinic for 8 weeks, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
- Conditions
- Low Testosterone
- Being tested
- TAK-448, TAK-448 Placebo
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-448Drug
TAK-448 solution for subcutaneous injection
TAK-448 PlaceboDrug
TAK-448 placebo-matching solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| TAK-448 0.1 mcg | Experimental | TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42. Receives: Drug: TAK-448 |
| TAK-448 0.3 mcg | Experimental | TAK-448 0.3 mcg, injection, subcutaneously, twice-weekly on Days 1 through 39. Receives: Drug: TAK-448 |
| TAK-448 1.0 mcg | Experimental | TAK-448 1.0 mcg, injection, subcutaneously, once-weekly on Days 1 through 36. Receives: Drug: TAK-448 |
| Placebo | Placebo comparator | TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36. Receives: Drug: TAK-448; Drug: TAK-448 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Average Serum Concentration (Cav) of Total ST After 6 Weeks of Dosing
Cav is the average serum concentration of the dosing interval, calculated as area under the effect curve (AUEC) divided by the duration of the dosing interval.
Measured: Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36
Trough Serum Concentration (Ctrough) of ST
Trough serum concentration of total and free ST, defined as lowest Baseline concentration.
Measured: Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36
Secondary outcomes (4)
Serum Testosterone Cmax: Maximum Observed Plasma Concentration
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Assessments were done Day 1 and Day 42 for once daily regimen, on Day 36 for once weekly regimen and on Day 39 for twice-weekly regimen (Day 42/36/39).
Measured: Day 1 (first dose) and Day 42 for once-daily regimen, Day 39 for twice-weekly regimen, or Day 36 for once-weekly regimen (last dose)
Cmax: Maximum Observed Plasma Concentration for the Free Form of TAK-448 (TAK-448F)
Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.
AUCt: Area Under the Plasma Concentration-Time Curve for TAK-448F
Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.
Measured: Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.
Terminal Elimination Half-life (T1/2) for TAK-448F
T1/2 is the time required for half of the drug to be eliminated from the plasma.
Measured: Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study start10 Sep 2015
- Primary completion8 Apr 2016
- Study completion8 Apr 2016
Why it stopped: Sponsor decision to terminate the study because the study did not meet the primary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low TestosteroneStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381288
- Sponsor's protocol ID
- TAK-448-2002
- Other IDs
- U1111-1150-2776
- Status last verified
- Apr 2017
- First submitted
- 2 Mar 2015
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Placebo-Controlled Phase 2a Study to Evaluate the Stimulatory Effects of TAK-448, a Kisspeptin Analog, Administered Intermittently in Middle-aged and Older Men With Low Testosterone
- ClinicalTrials.gov ID
- NCT02381288
- Acronym / sponsor ID
- TAK-448-2002
- Conditions
- Low Testosterone
- Keywords
- Drug therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to terminate the study because the study did not meet the primary endpoint.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2015 (actual)
- Primary completion
- 8 Apr 2016 (actual)
- Study completion
- 8 Apr 2016 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effects on serum testosterone (ST) after 6 weeks of subcutaneous (SC) administration of different doses and dosing frequencies of TAK-448 to middle-aged and older men with low ST levels.
Detailed description
The drug tested in this study is called TAK-448. TAK-448 was tested to define a dose and dose frequency which results in a clinically relevant improvement in ST in middle-aged and older men with low ST levels. This study looked at ST levels in men who took TAK-448.
The study enrolled 17 participants. Participants were randomly assigned (by chance, like flipping a coin) to one of the following treatment groups-which remained undisclosed to the participants and study doctor during the study (unless there is an urgent medical need):
- TAK-448 0.1 µg
- TAK-448 0.3 µg
- TAK-448 1.0 µg
- Placebo (dummy inactive injection) - this was a injection that looks like the study drug but has no active ingredient All participants received subcutaneous injection either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
This single-center trial was conducted in the United States. The overall time to participate in this study is up to 56 days. Participants made daily visits to the clinic for 8 weeks, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TAK-448 0.1 mcg | Experimental | Drug: TAK-448TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42. |
| TAK-448 0.3 mcg | Experimental | Drug: TAK-448TAK-448 0.3 mcg, injection, subcutaneously, twice-weekly on Days 1 through 39. |
| TAK-448 1.0 mcg | Experimental | Drug: TAK-448TAK-448 1.0 mcg, injection, subcutaneously, once-weekly on Days 1 through 36. |
| Placebo | Placebo comparator | Drug: TAK-448, Drug: TAK-448 PlaceboTAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has total serum testosterone (ST) levels less than 300 ng/dL at Screening.
- Has a body mass index (BMI) between 20.0 and 40.0 kg/m^2, inclusive at Screening.
- A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from the time of signing of informed consent throughout the duration of the study and for 12 weeks after the last dose.
Key exclusion criteria (14 listed)
- Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality that may impact the ability of the participant to participate or potentially confound the study results. Participants will be excluded based on:
- Has type 2 diabetes mellitus defined as fasting blood glucose >125 mg/dL, glycosylated hemoglobin (HbA1c) >6.2%, or use of antidiabetic medication (Cohort 2 only).
- Has clinical evidence of anatomic or pathological hypothalamic/pituitary/testicular disease, such as (but not limited to) Klinefelter's syndrome, Kallmann's syndrome, systemic infiltrative diseases (hemochromatosis, sarcoidosis, Wilson's disease), or prior pituitary surgery.
- Has used gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, antiandrogens, clomiphene, or other reproductive hormone-related agents within 6 months prior to Screening.
- Has used anabolic therapies (testosterone, dehydroepiandrosterone [DHEA], androstendione, any other androgen, or recombinant human growth hormone) within 1 year of Screening.
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 |
|---|---|---|
| TAK-448TAK-448 solution for subcutaneous injection | Drug | Placebo, TAK-448 0.1 mcg, TAK-448 0.3 mcg, TAK-448 1.0 mcg |
| TAK-448 PlaceboTAK-448 placebo-matching solution for subcutaneous injection | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Average Serum Concentration (Cav) of Total ST After 6 Weeks of Dosing
Time frame: Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36
Cav is the average serum concentration of the dosing interval, calculated as area under the effect curve (AUEC) divided by the duration of the dosing interval.
Trough Serum Concentration (Ctrough) of ST
Time frame: Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36
Trough serum concentration of total and free ST, defined as lowest Baseline concentration.
4 secondary outcomes
Serum Testosterone Cmax: Maximum Observed Plasma Concentration
Time frame: Day 1 (first dose) and Day 42 for once-daily regimen, Day 39 for twice-weekly regimen, or Day 36 for once-weekly regimen (last dose)
Cmax: Maximum Observed Plasma Concentration for the Free Form of TAK-448 (TAK-448F)
Time frame: Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.
AUCt: Area Under the Plasma Concentration-Time Curve for TAK-448F
Time frame: Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.
Terminal Elimination Half-life (T1/2) for TAK-448F
Time frame: Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director Clinical Science study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-448 in people with Low Testosterone, run by Takeda at 1 site in United States.
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 14 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: stopped early, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline in Average Serum Concentration (Cav) of Total ST After 6 Weeks of Dosing (time frame: Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36). The study lists 2 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 17 May 2017.