HealthyPhase 1NCT00776841
A Phase 1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
A Phase 1 study testing Aramchol in people with Healthy, run by Galmed Medical Reserch at 1 site in Israel.
Trial summary
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers. Primary Objectives: 1. To assess and characterize the safety and tolerability of Aramchol in 16 healthy male subjects at single doses ranging between 30 and 900 mg (Part A) and in… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aramchol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2008to Oct 2009
- 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part A: Healthy male volunteers aged 18-50 (inclusive) years who have provided written informed consent
- Part B: Mildly overweight (25<BMI <33), with fasting cholesterol levels of 200-300 mg/% or LDL 100-180 mg/% and triglycerides < 200 mg/%, otherwise healthy male volunteers aged 18-50 (inclusive) years, who have provided written informed consent
- Major Exclusion Criteria:
- History of significant neurological (including history of seizures or EEG abnormalities), renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety, tension or agitation) or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
- History of drug or alcohol abuse.
- Known allergy to any drug. Known allergy to any drug.
- Clinically significant abnormalities found in the screening physical exam.
- Significant abnormalities in clinical laboratory parameters (hematology, biochemistry, urinalysis) determined within 40 days of the start of the study and on Day (-1) before first dosing session. Parameters to be measured are those shown in Appendix 2.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers.
Primary Objectives:
- To assess and characterize the safety and tolerability of Aramchol in 16 healthy male subjects at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses (Part B)
- To assess the pharmacokinetics of Aramchol at the administered doses
Read the detailed description
Number of Subjects:
Total: A total of 46 healthy subjects will be enrolled. Part A: Sixteen (16) subjects will participate in four, 8-person dosing periods. Each cohort will be alternately dosed twice.
Part B: Thirty (30) subjects will be enrolled in two, 15-person dose-ascending cohorts.
Main Inclusion Criteria:
Part A: Healthy male volunteers aged 18-50 (inclusive) years who have provided written informed consent Part B: Mildly overweight (25<BMI<33), with fasting cholesterol levels of 200-300 mg/% or LDL 100-180 mg/% and triglycerides < 200 mg/%, otherwise healthy male volunteers aged 18-50 (inclusive) years, who have provided written informed consent
- Conditions
- Healthy
- Being tested
- Aramchol
- Keywords
- Phase-I, Hypercholesterolemia, Obesity, fatty liver, Part A: Healthy male volunteers Part B: Mildly overweight, otherwise healthy hypercholesterolemic male volunteers
- Medical subject headings
- Hypercholesterolemia, Obesity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AramcholDrug
Also called 3β-arachidylamido-7α,12α,dihydroxy 5β-cholan-24-oic acid), fatty-acid bile-acid conjugate
1.Aramchol in 16 healthy male subjects at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses (Part B)
AramcholDrug
Oral Aramchol at dose 30 mg to 900 mg
AramcholDrug
Oral Aramchol at doses 30 mg to 900 mg single dose and 30 mg and high dose for 4 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo control single dose Receives: Drug: Aramchol |
| Dose 1 | Experimental | Dose 30 mg Receives: Drug: Aramchol |
| Dose 2 | Experimental | Dose 100 mg Receives: Drug: Aramchol |
| Dose 3 | Experimental | Dose 300 mg Receives: Drug: Aramchol |
| Dose 4 | Experimental | Dose 900 mg Receives: Drug: Aramchol |
| Dose 1 repeated | Experimental | Dose 30 mg for 4 days Receives: Drug: Aramchol |
| Dose 2 repeated | Experimental | Dose high for 4 days Receives: Drug: Aramchol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety and tolerability and Pharmacokinetics of Aramchol at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, subjects receiving multiple doses (Part B)
Measured: day 1 to 6
Secondary outcomes (1)
To assess and characterize the drug effect on lipid profile and functional pharmacodynamics following single and multiple dose administrations.
Measured: day 1 to 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2009
- Study completionOct 2009
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galmed Medical Reserch
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jacob Atsmon, M.D., Principal investigator, TASMC CLINICAL RESEARCH CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776841
- Sponsor's protocol ID
- PROTOCOL No: TRC 037/10072
- Status last verified
- Nov 2010
- First submitted
- 19 Oct 2008
- Last updated
- 3 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00776841
- Acronym / sponsor ID
- PROTOCOL No: TRC 037/10072
- Conditions
- Healthy
- Keywords
- Phase-I, Hypercholesterolemia, Obesity, fatty liver, Part A: Healthy male volunteers Part B: Mildly overweight, otherwise healthy hypercholesterolemic male volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Galmed Medical ReserchIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 21 Oct 2008 (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.
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers.
Primary Objectives:
- To assess and characterize the safety and tolerability of Aramchol in 16 healthy male subjects at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses (Part B)
- To assess the pharmacokinetics of Aramchol at the administered doses
Detailed description
Number of Subjects:
Total: A total of 46 healthy subjects will be enrolled. Part A: Sixteen (16) subjects will participate in four, 8-person dosing periods. Each cohort will be alternately dosed twice.
Part B: Thirty (30) subjects will be enrolled in two, 15-person dose-ascending cohorts.
Main Inclusion Criteria:
Part A: Healthy male volunteers aged 18-50 (inclusive) years who have provided written informed consent Part B: Mildly overweight (25<BMI<33), with fasting cholesterol levels of 200-300 mg/% or LDL 100-180 mg/% and triglycerides < 200 mg/%, otherwise healthy male volunteers aged 18-50 (inclusive) years, who have provided written informed consent
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: AramcholPlacebo control single dose |
| Dose 1 | Experimental | Drug: AramcholDose 30 mg |
| Dose 2 | Experimental | Drug: AramcholDose 100 mg |
| Dose 3 | Experimental | Drug: AramcholDose 300 mg |
| Dose 4 | Experimental | Drug: AramcholDose 900 mg |
| Dose 1 repeated | Experimental | Drug: AramcholDose 30 mg for 4 days |
| Dose 2 repeated | Experimental | Drug: AramcholDose high for 4 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Part A: Healthy male volunteers aged 18-50 (inclusive) years who have provided written informed consent
- Part B: Mildly overweight (25<BMI <33), with fasting cholesterol levels of 200-300 mg/% or LDL 100-180 mg/% and triglycerides < 200 mg/%, otherwise healthy male volunteers aged 18-50 (inclusive) years, who have provided written informed consent
- History of significant neurological (including history of seizures or EEG abnormalities), renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety, tension or agitation) or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
- History of drug or alcohol abuse.
- Known allergy to any drug. Known allergy to any drug.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AramcholAlso: 3β-arachidylamido-7α,12α,dihydroxy 5β-cholan-24-oic acid), fatty-acid bile-acid conjugate1.Aramchol in 16 healthy male subjects at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses (Part B) | Drug | Dose 1, Dose 1 repeated, Dose 2, Dose 2 repeated, Dose 3, Dose 4, Placebo |
| AramcholOral Aramchol at dose 30 mg to 900 mg | Drug | Dose 1, Dose 2, Dose 3, Dose 4, Placebo |
| AramcholOral Aramchol at doses 30 mg to 900 mg single dose and 30 mg and high dose for 4 days | Drug | Dose 1, Dose 1 repeated, Dose 2, Dose 2 repeated, Dose 3, Dose 4, Placebo |
Primary outcome
To assess safety and tolerability and Pharmacokinetics of Aramchol at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, subjects receiving multiple doses (Part B)
Time frame: day 1 to 6
1 secondary outcome
To assess and characterize the drug effect on lipid profile and functional pharmacodynamics following single and multiple dose administrations.
Time frame: day 1 to 6
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 3 Nov 2010.
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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.
Jacob Atsmon, M.D. principal investigator
TASMC CLINICAL RESEARCH CENTER
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 Aramchol in people with Healthy, run by Galmed Medical Reserch at 1 site in Israel.
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 8 inclusion and 0 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 3 Nov 2010. 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 Israel. 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?
To assess safety and tolerability and Pharmacokinetics of Aramchol at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, subjects receiving multiple doses (Part B) (time frame: day 1 to 6). 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 3 Nov 2010.