HealthyPhase 1NCT01440166
Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers
A Phase 1 study testing Drug in people with Healthy, run by Catabasis Pharmaceuticals at 1 site in United States.
Trial summary
To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative to placebo in healthy adult volunteers. To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jan 2012
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good health.
- Age: 19 to 55 years inclusive at Screening.
- Satisfies one of the following
- Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal, OR
- Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose.
- BMI: 18 to 30 kg/m2 at Screening.
Who cannot join
- Clinically significant abnormalities in physical examination or vital signs.
- Clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator.
- Clinically significant screening laboratory result as assessed by the Investigator.
- The subject has a history of clinically significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), or hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- History or presence of malignancy with the past 5 years.
- History of alcohol or substance abuse or eating disorder within 2 years, OR regular use of alcohol within 6 months (>14 units of alcohol per week; 1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
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- Use of any investigational drug or participation in any investigational study within 30 days prior to screening. For dose levels 6 and 7 fed cohorts, subjects may participate who have taken part in the dose levels 4 and 5 fasted cohort.
- Any significant blood loss within 60 days prior to screening, e.g. blood donation, participation in study with multiple blood draws, etc.
- Any condition, disease, disorder or clinically relevant laboratory abnormality that, in the opinion of the Investigator, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment.
- A suspected allergy or sensitivity to CAT-1004 or excipients based upon known allergies to excipients or compounds of a similar class.
- Any clinically significant systemic infection within 3 weeks prior to screening.
- Use of prescription medications within 30 days of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Celerion Clinical Research Unit
Lincoln, Nebraska, 68502
About this study
Official title: A Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers
- To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative to placebo in healthy adult volunteers.
- To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy adult volunteers.
- To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult volunteers.
- Conditions
- Healthy
- Being tested
- Drug, Placebo
- Keywords
- Human healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrugDrug
Also called CAT-1004
Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
PlaceboOther
Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 / Dose level 1 | Experimental | Single dose orally: CAT-1004 Dose level 1 or placebo Receives: Drug: Drug; Other: Placebo |
| Cohort 2 / Dose level 2 | Experimental | Single dose orally: CAT-1004 Dose level 2 or placebo Receives: Drug: Drug; Other: Placebo |
| Cohort 3 /Dose level 3 | Experimental | Single dose orally: CAT-1004 Dose level 3 or placebo Receives: Drug: Drug; Other: Placebo |
| Cohort 4/ Dose level 4 | Experimental | Single dose orally: CAT-1004 Dose level 4 or placebo Receives: Drug: Drug; Other: Placebo |
| Cohort 5/ Dose level 5 | Experimental | Single dose orally: CAT-1004 Dose level 5 or placebo Receives: Drug: Drug; Other: Placebo |
| Cohort 2/ Dose level 2 ( FE) | Experimental | Single dose orally (Under fed conditions): CAT-1004 Dose level 2 or placebo Receives: Drug: Drug; Other: Placebo |
| Cohort 3/ Dose level 3 (FE) | Experimental | Single dose orally (Under fed conditions): CAT-1004 Dose level 3 or placebo Receives: Drug: Drug; Other: Placebo |
| Cohort 6 / Dose level 6 (FE) | Experimental | Single dose orally (Under fed conditions) CAT-1004 Dose level 4 or placebo Subjects may be reenrolled from Cohort 4. Receives: Drug: Drug; Other: Placebo |
| Cohort 7 / Dose level 7 (FE) | Experimental | Single dose orally (Under fed conditions)CAT-1004 Dose level 5 or placebo Subjects may be reenrolled from Cohort 5. Receives: Drug: Drug; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety Endpoints: Laboratory evaluations including hematology, chemistry, coagulation and urinalysis, physical examinations, AEs, serious AEs (SAEs), ECGs, and vital signs.
Measured: Change from Baseline versus Day-1 though 72 hrs post dose and EOT/FU
Secondary outcomes (1)
Pharmacokinetic Profile
The following noncompartmental PK parameters will be calculated: area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf), area under concentration-time curve from time 0 to time of last quantifiable concentration (AUClast), maximum observed plasma concentration (Cmax), time to first occurrence of Cmax (Tmax), terminal phase elimination half-life (t½), apparent oral clearance (CL/F), and volume of distribution during the terminal phase (Vz/F). Additional PK parameters may be calculated if deemed appropriate.
Measured: Plasma blood samples through 72 hrs, urine collections through 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catabasis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Rasmussen, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440166
- Sponsor's protocol ID
- CAT-1004-101
- Status last verified
- Feb 2012
- First submitted
- 8 Sep 2011
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01440166
- Acronym / sponsor ID
- CAT-1004-101
- Conditions
- Healthy
- Keywords
- Human healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Catabasis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Sep 2011 (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.
- To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative to placebo in healthy adult volunteers.
- To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy adult volunteers.
- To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 / Dose level 1 | Experimental | Drug: Drug, Other: PlaceboSingle dose orally: CAT-1004 Dose level 1 or placebo |
| Cohort 2 / Dose level 2 | Experimental | Drug: Drug, Other: PlaceboSingle dose orally: CAT-1004 Dose level 2 or placebo |
| Cohort 3 /Dose level 3 | Experimental | Drug: Drug, Other: PlaceboSingle dose orally: CAT-1004 Dose level 3 or placebo |
| Cohort 4/ Dose level 4 | Experimental | Drug: Drug, Other: PlaceboSingle dose orally: CAT-1004 Dose level 4 or placebo |
| Cohort 5/ Dose level 5 | Experimental | Drug: Drug, Other: PlaceboSingle dose orally: CAT-1004 Dose level 5 or placebo |
| Cohort 2/ Dose level 2 ( FE) | Experimental | Drug: Drug, Other: PlaceboSingle dose orally (Under fed conditions): CAT-1004 Dose level 2 or placebo |
| Cohort 3/ Dose level 3 (FE) | Experimental | Drug: Drug, Other: PlaceboSingle dose orally (Under fed conditions): CAT-1004 Dose level 3 or placebo |
| Cohort 6 / Dose level 6 (FE) | Experimental | Drug: Drug, Other: PlaceboSingle dose orally (Under fed conditions) CAT-1004 Dose level 4 or placebo Subjects may be reenrolled from Cohort 4. |
| Cohort 7 / Dose level 7 (FE) | Experimental | Drug: Drug, Other: PlaceboSingle dose orally (Under fed conditions)CAT-1004 Dose level 5 or placebo Subjects may be reenrolled from Cohort 5. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In good health.
- Age: 19 to 55 years inclusive at Screening.
- Satisfies one of the following
- BMI: 18 to 30 kg/m2 at Screening.
Key exclusion criteria (12 listed)
- Clinically significant abnormalities in physical examination or vital signs.
- Clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator.
- Clinically significant screening laboratory result as assessed by the Investigator.
- The subject has a history of clinically significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), or hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- History or presence of malignancy with the past 5 years.
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 |
|---|---|---|
| DrugAlso: CAT-1004Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort. | Drug | Cohort 1 / Dose level 1, Cohort 2 / Dose level 2, Cohort 2/ Dose level 2 ( FE), Cohort 3 /Dose level 3, Cohort 3/ Dose level 3 (FE), Cohort 4/ Dose level 4, Cohort 5/ Dose level 5, Cohort 6 / Dose level 6 (FE), Cohort 7 / Dose level 7 (FE) |
| PlaceboSingle dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort. | Other | Cohort 1 / Dose level 1, Cohort 2 / Dose level 2, Cohort 2/ Dose level 2 ( FE), Cohort 3 /Dose level 3, Cohort 3/ Dose level 3 (FE), Cohort 4/ Dose level 4, Cohort 5/ Dose level 5, Cohort 6 / Dose level 6 (FE), Cohort 7 / Dose level 7 (FE) |
Primary outcome
Safety
Time frame: Change from Baseline versus Day-1 though 72 hrs post dose and EOT/FU
Safety Endpoints: Laboratory evaluations including hematology, chemistry, coagulation and urinalysis, physical examinations, AEs, serious AEs (SAEs), ECGs, and vital signs.
1 secondary outcome
Pharmacokinetic Profile
Time frame: Plasma blood samples through 72 hrs, urine collections through 48 hrs
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 6 Feb 2012.
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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.
Scott Rasmussen, MD principal investigator
Celerion
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 Drug in people with Healthy, run by Catabasis Pharmaceuticals 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 6 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 6 Feb 2012. 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. 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?
Safety (time frame: Change from Baseline versus Day-1 though 72 hrs post dose and EOT/FU). 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 6 Feb 2012.