Muscle AtrophyPhase 1NCT01524406
Safety Study of HPP593 in Subjects During and After Limb Immobilization
A Phase 1 study testing HPP593 in people with Muscle Atrophy and Hypodynamia, run by High Point Pharmaceuticals, LLC. at 1 site in United States.
Trial summary
This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy, Hypodynamia
- What is being tested?
- HPP593
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2013
- 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 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking.
- Subjects must be in good health, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical test results.
- Not restricted to a wheel-chair or confined to a bed.
- Weight ≥ 50.0 kg.
- BMI between 18 and 27.5 kg/m2, inclusive, at the time of screening.
Who cannot join
- Any of the following abnormalities at Screening Visit and Baseline:
- Fasting glucose > 110 mg/dL (Screening visit only).
- Serum creatinine > 1.5 mg/dL. If serum creatinine is >1.5 mg/dL and creatinine clearance is >60 mL/min, the subject need not be excluded
- Troponin I level above the upper limit of normal (ULN)
- Liver function tests (LFTs) > 1.5x ULN
- Evidence of significant organ system dysfunction (e.g. diabetes, cardiovascular disease, cirrhosis, hypogonadism, hypo- or hyperthyroidism; hypertension)
Show all 10Show fewer
- Any fluctuations in weight (no more than ± 2% of body weight) by subject self report in the 3 months prior to the Screening Visit.
- Has received HPP593 in a previous clinical trial.
- Smoking within 6 month prior to Day -1.
- Michigan Alcohol Screening Test score greater than 2.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine Division of Geriatrics and Nutritional Studies
St Louis, Missouri, 63110
About this study
Official title: A Randomized, Double-blind, Placebo Controlled, Phase I Study to Evaluate the Safety and Tolerability of 28 Day Treatment With HPP593 Capsules in Healthy Volunteers During and After Limb Immobilization
This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.
- Conditions
- Muscle Atrophy, Hypodynamia
- Being tested
- HPP593, Placebo
- Keywords
- Muscle Atrophy
- Medical subject headings
- Muscular Atrophy, Hypokinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPP593Drug
Oral, twice a day.
PlaceboDrug
Oral, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| HPP593 | Experimental | Not described Receives: Drug: HPP593 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation
Number and severity of adverse events across trial period
Measured: Baseline to Day 42
Secondary outcomes (2)
Change in Muscle Strength
Measured: Day 1 to Day 42
Changes on Muscle Related Biomarkers
Measured: Day 1 to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle AtrophyStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Point Pharmaceuticals, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shulin Wang, M.D., Study director, High Point Pharmaceuticals, LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524406
- Sponsor's protocol ID
- HPP593-103
- Status last verified
- Jul 2014
- First submitted
- 27 Jan 2012
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled, Phase I Study to Evaluate the Safety and Tolerability of 28 Day Treatment With HPP593 Capsules in Healthy Volunteers During and After Limb Immobilization
- ClinicalTrials.gov ID
- NCT01524406
- Acronym / sponsor ID
- HPP593-103
- Conditions
- Muscle Atrophy, Hypodynamia
- Keywords
- Muscle Atrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- High Point Pharmaceuticals, LLC.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Feb 2012 (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.
This is a safety and tolerability study investigating the effect of HPP593 in healthy volunteers during and after limb immobilization.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPP593 | Experimental | Drug: HPP593 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non-smoking.
- Subjects must be in good health, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical test results.
- Not restricted to a wheel-chair or confined to a bed.
- Weight ≥ 50.0 kg.
- BMI between 18 and 27.5 kg/m2, inclusive, at the time of screening.
Key exclusion criteria (10 listed)
- Any of the following abnormalities at Screening Visit and Baseline:
- Evidence of significant organ system dysfunction (e.g. diabetes, cardiovascular disease, cirrhosis, hypogonadism, hypo- or hyperthyroidism; hypertension)
- Any fluctuations in weight (no more than ± 2% of body weight) by subject self report in the 3 months prior to the Screening Visit.
- Has received HPP593 in a previous clinical trial.
- Smoking within 6 month prior to Day -1.
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 |
|---|---|---|
| HPP593Oral, twice a day. | Drug | HPP593 |
| PlaceboOral, twice a day. | Drug | Placebo |
Primary outcome
Safety Evaluation
Time frame: Baseline to Day 42
Number and severity of adverse events across trial period
2 secondary outcomes
Change in Muscle Strength
Time frame: Day 1 to Day 42
Changes on Muscle Related Biomarkers
Time frame: Day 1 to Day 29
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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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.
Shulin Wang, M.D. study director
High Point Pharmaceuticals, LLC.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HPP593 in people with Muscle Atrophy and Hypodynamia, run by High Point Pharmaceuticals, LLC. 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 5 inclusion and 10 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 15 Jul 2014. 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 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 was stopped early. Results are not available in the source record.
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?
Safety Evaluation (time frame: Baseline to Day 42). 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 Jul 2014.