Healthy VolunteersPhase 1NCT02803996
Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol Administered Under Fed Conditions in Healthy Chinese Volunteers
A Phase 1 study testing Aramchol in people with Healthy Volunteers, run by Galmed Pharmaceuticals Ltd at 1 site in United States.
Trial summary
This is a single-site, randomized, double-blind, double dummy, placebo-controlled single and multiple doses study of Aramchol in healthy Chinese volunteers. The subject population that was enrolled for Aramchol 004 was not specifically designed to understand the PK profile of Aramchol in subjects of Chinese descent. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- 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
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Dec 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects, born in China, both parents of Chinese descent, aged at screening between 18-50 years old (inclusive), and having not lived outside of China for more than 10 years (in total, confirmed by verbal report).
- BMI ≥ 18.0 and ≤ 30.0.
- Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs and physical examination.
- No significant abnormalities in ECG (eg, prolonged QTcF, prolonged PR interval) done at screening and on Days (0) before dosing session.
- No clinically significant abnormalities in hematology, blood chemistry, or urinalysis lab tests at screening.
- No known history of alcohol or drug abuse. Subjects with negative urinary drugs of abuse (DOA) screen determined on Day (0) before dosing session(s).
Show all 17Show fewer
- Negative human immunodeficiency virus (HIV), hepatitis B, and hepatitis C serology tests as evaluated at screening.
- Negative urine pregnancy tests at screening and at check-in (women of childbearing potential only).
- . Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- All subjects must agree to use a highly effective method of birth control during the study and up to 15 days after the last study drug administration. A highly effective method of birth control is considered to be one of the following:
- An oral or implanted hormonal method of contraception (if it had been used for ≥3 months prior to study drug administration) while also using a barrier method (ie, condom or diaphragm)
- A hormone or copper intrauterine device if it had been in place for ≥3 months prior to study drug administration (subjects using nonhormonal or copper intrauterine devices were also required to use a barrier method of contraception)
- A vasectomized partner
- Total abstinence is acceptable; however, the subject is required to use a highly effective method of contraception if the subject decides subsequently not to abstain
- Periodic abstinence around ovulation is not considered acceptable
- Women who are either surgically sterilized or postmenopausal (last menstrual period at least 1 year prior to the screening visit) are exempt from this requirement. If medical records are not available to document sterility, urine pregnancy testing will be performed at screening and check-in.
- Subjects must provide written informed consent to participate in the study.
Who cannot join
- Documented history or on-going symptoms of any gastrointestinal disorder involving motility, gastric acid or gastric emptying or malabsorption, including but not limited to, peptic ulcer disease, gastroesophageal reflux, dyspepsia, gastroparesis, chronic diarrhea, chronic constipation, gall bladder disease, pancreatitis, lactose intolerance and celiac disease.
- History of esophageal, gastric, biliary, or intestinal surgery (excluding herniotomy and appendectomy which are not related to gastrointestinal disorders).
- Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
- Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at screening visit.
- Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements within 14 days prior to dosing. Paracetamol or ibuprofen for symptomatic relief of pain is allowed until 24 hours prior to the study drug administration.
- Subjects who have taken anticholinergic or other drugs known to affect gastrointestinal motility within 7 days prior to the first dosing.
Show all 15Show fewer
- Treatment with any drugs with known hepatic enzyme-inducing or inhibiting agents (eg, barbiturates, phenothiazines, cimetidine, carbamazepine) within 30 days prior to dosing.
- Known clinically significant hypersensitivity and/or allergy to any drugs.
- Subjects with recent significant change in body weight (±10% within 3 months of screening).
- Any acute illness (eg, acute infection) within 48 hours prior to the first study drug administration, which is considered of significance by the Principal Investigator.
- Participation in another clinical trial with drugs, received within 3 months prior to dosing (calculated from the previous study's last dosing date).
- Female subjects who are pregnant or breastfeeding.
- Subjects who donated blood in the three months or received blood or plasma derivatives in the six months preceding study drug administration.
- Inability to fast or consume the food provided in the study (including any clinically significant known food allergies or food restrictions).
- Subjects who are non-cooperative, unwilling or unable to communicate with the investigators and site staff (ie, language problem, poor mental development or impaired cerebral function).
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-site, randomized, double-blind, double dummy, placebo-controlled single and multiple doses study of Aramchol in healthy Chinese volunteers. The subject population that was enrolled for Aramchol 004 was not specifically designed to understand the PK profile of Aramchol in subjects of Chinese descent. Therefore, this study (Aramchol 015) has been undertaken to ascertain the PK profile of Aramchol following single and multiple doses in a Chinese population under fed conditions utilizing the light breakfast from Aramchol 004.
This study will consist of two parts and the subjects will be assigned to two parts.
In each part of the study, subjects will be enrolled in the study within 28 days of screening.
Read the detailed description
In each part of the study, subjects will be enrolled in the study within 28 days of screening. The study will consist of two parts, and the subjects will be assigned as follows: Part A- single escalating doses This part of the study is a single-site, randomized, double-blind, double dummy, placebo-controlled single-dose study of Aramchol in healthy Chinese volunteers. The purpose of Part A is to evaluate the PK, safety and tolerability of Aramchol tablets at single doses of either 400 mg or 600 mg.
Thirty-two (32) subjects will participate in this part of the study and will be randomized to receive a single-dose of 400 mg Aramchol, 600 mg Aramchol, or Placebo. Drug administration will be preceded by a light breakfast consumed within 1 hour prior to dosing. All drugs will be administered by the study staff. In order to maintain blinding, all subjects will receive two tablets on each dosing, according to the following administrations:
- Cohort A: 1 x 200 mg Placebo tablet + 1 x 400 mg Aramchol tablet (12 subjects)
- Cohort B: 1 x 200 mg Aramchol tablet + 1 x 400 mg Aramchol tablet (12 subjects)
- Cohort C: 1 x 200mg Placebo tablet + 1 x 400 mg Placebo tablet (8 subjects) Subjects will be admitted in-house in the evening before the first study drug administration (Day 0) and will remain in-house for 36 hours after dosing. Blood samples for Aramchol concentrations will be drawn for 36 hours at designated time points as described below. Additional ambulatory samples will be collected at 48, 72, 96, and 144 hours postdose. Subjects will be continuously monitored for safety. An End-of Study/Safety Follow-up visit will take place on the last PK sampling day, ie, 144 hours after the last dose administration.
If the PK profile from Part A is similar to the existing PK data in non- Chinese subjects, then the study may be stopped. If the PK profile is different, then Part B of the study may be performed.
Part B- multiple escalating doses Part B of the study is a single-site, randomized, double-blind, doubledummy, placebo-controlled multiple-dose study of Aramchol in healthy Chinese volunteers. The purpose of this part is to evaluate the PK, safety and tolerability of Aramchol tablets at multiple administrations of two different doses. Thirty-two (32) subjects will participate in this part of the study and will be equally randomized to receive 400 mg Aramchol, 600 mg Aramchol, or Placebo for 10 consecutive days. Screening for Part B may begin during PK analysis of Part A. Part A subjects can enroll into Part B with sponsor approval. Drug administration will be preceded by a light breakfast consumed within 1 hour prior to dosing. All drugs will be administered by the study staff. In order to maintain blinding, all subjects will receive two tablets on each dosing, according to the following administrations:
- Cohort D: 1 x 200 mg Placebo tablet + 1 x 400 mg Aramchol tablet (12 subjects)
- Cohort E: 1 x 200 mg Aramchol tablet + 1 x 400 mg Aramchol tablet (12 subjects)
- Cohort F: 1 x 200 mg Placebo tablet + 1 x 400 mg Placebo tablet (8 subjects) Subjects will be admitted in-house in the evening before the first study drug administration (Day 0) and will remain in-house for 24 and 36 hours after first (Day 1) and last (Day 10) doses, respectively; subjects will return for all other visits. PK blood samples will be drawn on Day 1 over 24 hours at designated time points as described below. Additionally, pre-dose (trough) samples will be drawn before dosing on Days 2, 3, 4, 5, 7, 8, and 9. On Day 10, blood samples will be collected over 36 hours at designated time points as described below and during additional visits at 48, 96, 120, 144, 168 and 192 hours post-dose. Subjects will be continuously monitored for safety. An End-of Study/Safety Follow-up visit will take place on the last PK sampling day, ie, 192 hours after the last dose administration.
- Conditions
- Healthy Volunteers
- Being tested
- Aramchol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AramcholDrug
Part A: Aramchol oral tablets at 400 mg or 600 mg single dose Part B: Aramchol oral tablets at 400 mg or 600 mg multiple dose for 10 consecutive days.
PlaceboDrug
Part A: Placebo oral tablets single dose Part B: Placebo oral tablets multiple dose for 10 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Part A- Single Dose- 400 mg Aramchol | Active comparator | Part A: Subjects will receive a single dose of 400 mg Aramchol, 600 mg Aramchol or placebo. Receives: Drug: Aramchol |
| Part A- Single Dose- 600 mg Aramchol | Active comparator | Part A: Subjects will receive a single dose of 400 mg Aramchol, 600 mg Aramchol or placebo. Receives: Drug: Aramchol |
| Part A-Single Dose-Placebo | Placebo comparator | Part A: Subjects will receive a single dose of 400 mg Aramchol, 600 mg Aramchol or placebo. Receives: Drug: Placebo |
| Part B-Multiple Dose-400 mg Aramchol | Active comparator | Part B: Subjects will receive multiple doses of 400 mg Aramchol, 600 mg Aramchol or placebo tablets for 10 consecutive days. Receives: Drug: Aramchol |
| Part B-Multiple Dose-600 mg Aramchol | Active comparator | Part B: Subjects will receive multiple doses of 400 mg Aramchol, 600 mg Aramchol or placebo tablets for 10 consecutive days. Receives: Drug: Aramchol |
| Part B-Multiple Dose-Placebo | Placebo comparator | Part B: Subjects will receive multiple doses of 400 mg Aramchol, 600 mg Aramchol or placebo tablets for 10 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax)
Measured: Part A:Pre-dose (within 60 min before dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 30, 36, 48(±60 min), 72 (±60 min), 96 (±60 min), 144 (±60 min) hours post-dose.Part C: Dosing days 1-10
Area under the plasma concentration time curve (AUC)
Measured: Part A:Pre-dose (within 60 min before dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 30, 36, 48(±60 min), 72 (±60 min), 96 (±60 min), 144 (±60 min) hours post-dose.Part C: Dosing days 1-10.
Maximum plasma concentration (Cmax)
Measured: Part B: Day 1 and day 10
Area under the plasma concentration time curve (AUC)
Measured: Part C: Day 1 and Day 10
Secondary outcomes (4)
Adverse Event (AE) Profile
Adverse Events records in patients file
Measured: Part A:Pre-dose (within 60 min before dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 30, 36, 48(±60 min), 72 (±60 min), 96 (±60 min), 144 (±60 min) hours post-dose. Part B:Dosing days 1-10
Adverse Event (AE) Profile
Adverse Events records in patients file
Measured: Part B: Dosing days 1 and 2: pre-dose (within 60 min before first dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18 and 24 (before second dosing) hours after drug administration+ day 3-10
Clinical Laboratory Safety Tests
Blood Tests
Measured: Part A:Pre-dose (within 60 min before dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 30, 36, 48(±60 min), 72 (±60 min), 96 (±60 min), 144 (±60 min) hours post-dose. Part B:Dosing days 1-10
Clinical Laboratory Safety Tests
Blood Tests
Measured: Part B:Dosing days 1 and 2: pre-dose (within 60 min before first dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18 and 24 (before second dosing) hours after drug administration+ day 3-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galmed Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WCCT Global, Alpha IRB, Analyst Research Laboratories, Kramer Consulting, LLC, Diamond Pharma Services Regulatory Affairs Consultancy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803996
- Sponsor's protocol ID
- Aramchol 015
- Status last verified
- Dec 2016
- First submitted
- 7 Jun 2016
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol Administered Under Fed Conditions in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT02803996
- Acronym / sponsor ID
- Aramchol 015
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Galmed Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Collaborators
- WCCT Global, Alpha IRB, Analyst Research Laboratories, Kramer Consulting, LLC, Diamond Pharma Services Regulatory Affairs Consultancy
- Study start
- May 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Jun 2016 (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 single-site, randomized, double-blind, double dummy, placebo-controlled single and multiple doses study of Aramchol in healthy Chinese volunteers. The subject population that was enrolled for Aramchol 004 was not specifically designed to understand the PK profile of Aramchol in subjects of Chinese descent. Therefore, this study (Aramchol 015) has been undertaken to ascertain the PK profile of Aramchol following single and multiple doses in a Chinese population under fed conditions utilizing the light breakfast from Aramchol 004.
This study will consist of two parts and the subjects will be assigned to two parts.
In each part of the study, subjects will be enrolled in the study within 28 days of screening.
Detailed description
In each part of the study, subjects will be enrolled in the study within 28 days of screening. The study will consist of two parts, and the subjects will be assigned as follows: Part A- single escalating doses This part of the study is a single-site, randomized, double-blind, double dummy, placebo-controlled single-dose study of Aramchol in healthy Chinese volunteers. The purpose of Part A is to evaluate the PK, safety and tolerability of Aramchol tablets at single doses of either 400 mg or 600 mg.
Thirty-two (32) subjects will participate in this part of the study and will be randomized to receive a single-dose of 400 mg Aramchol, 600 mg Aramchol, or Placebo. Drug administration will be preceded by a light breakfast consumed within 1 hour prior to dosing. All drugs will be administered by the study staff. In order to maintain blinding, all subjects will receive two tablets on each dosing, according to the following administrations:
- Cohort A: 1 x 200 mg Placebo tablet + 1 x 400 mg Aramchol tablet (12 subjects)
- Cohort B: 1 x 200 mg Aramchol tablet + 1 x 400 mg Aramchol tablet (12 subjects)
- Cohort C: 1 x 200mg Placebo tablet + 1 x 400 mg Placebo tablet (8 subjects) Subjects will be admitted in-house in the evening before the first study drug administration (Day 0) and will remain in-house for 36 hours after dosing. Blood samples for Aramchol concentrations will be drawn for 36 hours at designated time points as described below. Additional ambulatory samples will be collected at 48, 72, 96, and 144 hours postdose. Subjects will be continuously monitored for safety. An End-of Study/Safety Follow-up visit will take place on the last PK sampling day, ie, 144 hours after the last dose administration.
If the PK profile from Part A is similar to the existing PK data in non- Chinese subjects, then the study may be stopped. If the PK profile is different, then Part B of the study may be performed.
Part B- multiple escalating doses Part B of the study is a single-site, randomized, double-blind, doubledummy, placebo-controlled multiple-dose study of Aramchol in healthy Chinese volunteers. The purpose of this part is to evaluate the PK, safety and tolerability of Aramchol tablets at multiple administrations of two different doses. Thirty-two (32) subjects will participate in this part of the study and will be equally randomized to receive 400 mg Aramchol, 600 mg Aramchol, or Placebo for 10 consecutive days. Screening for Part B may begin during PK analysis of Part A. Part A subjects can enroll into Part B with sponsor approval. Drug administration will be preceded by a light breakfast consumed within 1 hour prior to dosing. All drugs will be administered by the study staff. In order to maintain blinding, all subjects will receive two tablets on each dosing, according to the following administrations:
- Cohort D: 1 x 200 mg Placebo tablet + 1 x 400 mg Aramchol tablet (12 subjects)
- Cohort E: 1 x 200 mg Aramchol tablet + 1 x 400 mg Aramchol tablet (12 subjects)
- Cohort F: 1 x 200 mg Placebo tablet + 1 x 400 mg Placebo tablet (8 subjects) Subjects will be admitted in-house in the evening before the first study drug administration (Day 0) and will remain in-house for 24 and 36 hours after first (Day 1) and last (Day 10) doses, respectively; subjects will return for all other visits. PK blood samples will be drawn on Day 1 over 24 hours at designated time points as described below. Additionally, pre-dose (trough) samples will be drawn before dosing on Days 2, 3, 4, 5, 7, 8, and 9. On Day 10, blood samples will be collected over 36 hours at designated time points as described below and during additional visits at 48, 96, 120, 144, 168 and 192 hours post-dose. Subjects will be continuously monitored for safety. An End-of Study/Safety Follow-up visit will take place on the last PK sampling day, ie, 192 hours after the last dose administration.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A- Single Dose- 400 mg Aramchol | Active comparator | Drug: AramcholPart A: Subjects will receive a single dose of 400 mg Aramchol, 600 mg Aramchol or placebo. |
| Part A- Single Dose- 600 mg Aramchol | Active comparator | Drug: AramcholPart A: Subjects will receive a single dose of 400 mg Aramchol, 600 mg Aramchol or placebo. |
| Part A-Single Dose-Placebo | Placebo comparator | Drug: PlaceboPart A: Subjects will receive a single dose of 400 mg Aramchol, 600 mg Aramchol or placebo. |
| Part B-Multiple Dose-400 mg Aramchol | Active comparator | Drug: AramcholPart B: Subjects will receive multiple doses of 400 mg Aramchol, 600 mg Aramchol or placebo tablets for 10 consecutive days. |
| Part B-Multiple Dose-600 mg Aramchol | Active comparator | Drug: AramcholPart B: Subjects will receive multiple doses of 400 mg Aramchol, 600 mg Aramchol or placebo tablets for 10 consecutive days. |
| Part B-Multiple Dose-Placebo | Placebo comparator | Drug: PlaceboPart B: Subjects will receive multiple doses of 400 mg Aramchol, 600 mg Aramchol or placebo tablets for 10 consecutive days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Healthy male and female subjects, born in China, both parents of Chinese descent, aged at screening between 18-50 years old (inclusive), and having not lived outside of China for more than 10 years (in total, confirmed by verbal report).
- BMI ≥ 18.0 and ≤ 30.0.
- Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs and physical examination.
- No significant abnormalities in ECG (eg, prolonged QTcF, prolonged PR interval) done at screening and on Days (0) before dosing session.
- No clinically significant abnormalities in hematology, blood chemistry, or urinalysis lab tests at screening.
Key exclusion criteria (15 listed)
- Documented history or on-going symptoms of any gastrointestinal disorder involving motility, gastric acid or gastric emptying or malabsorption, including but not limited to, peptic ulcer disease, gastroesophageal reflux, dyspepsia, gastroparesis, chronic diarrhea, chronic constipation, gall bladder disease, pancreatitis, lactose intolerance and celiac disease.
- History of esophageal, gastric, biliary, or intestinal surgery (excluding herniotomy and appendectomy which are not related to gastrointestinal disorders).
- Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
- Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at screening visit.
- Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements within 14 days prior to dosing. Paracetamol or ibuprofen for symptomatic relief of pain is allowed until 24 hours prior to the study drug administration.
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 |
|---|---|---|
| AramcholPart A: Aramchol oral tablets at 400 mg or 600 mg single dose Part B: Aramchol oral tablets at 400 mg or 600 mg multiple dose for 10 consecutive days. | Drug | Part A- Single Dose- 400 mg Aramchol, Part A- Single Dose- 600 mg Aramchol, Part B-Multiple Dose-400 mg Aramchol, Part B-Multiple Dose-600 mg Aramchol |
| PlaceboPart A: Placebo oral tablets single dose Part B: Placebo oral tablets multiple dose for 10 consecutive days. | Drug | Part A-Single Dose-Placebo, Part B-Multiple Dose-Placebo |
Primary outcome
Maximum plasma concentration (Cmax)
Time frame: Part A:Pre-dose (within 60 min before dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 30, 36, 48(±60 min), 72 (±60 min), 96 (±60 min), 144 (±60 min) hours post-dose.Part C: Dosing days 1-10
Area under the plasma concentration time curve (AUC)
Time frame: Part A:Pre-dose (within 60 min before dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 30, 36, 48(±60 min), 72 (±60 min), 96 (±60 min), 144 (±60 min) hours post-dose.Part C: Dosing days 1-10.
Maximum plasma concentration (Cmax)
Time frame: Part B: Day 1 and day 10
Area under the plasma concentration time curve (AUC)
Time frame: Part C: Day 1 and Day 10
4 secondary outcomes
Adverse Event (AE) Profile
Time frame: Part A:Pre-dose (within 60 min before dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 30, 36, 48(±60 min), 72 (±60 min), 96 (±60 min), 144 (±60 min) hours post-dose. Part B:Dosing days 1-10
Adverse Event (AE) Profile
Time frame: Part B: Dosing days 1 and 2: pre-dose (within 60 min before first dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18 and 24 (before second dosing) hours after drug administration+ day 3-10
Clinical Laboratory Safety Tests
Time frame: Part A:Pre-dose (within 60 min before dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 30, 36, 48(±60 min), 72 (±60 min), 96 (±60 min), 144 (±60 min) hours post-dose. Part B:Dosing days 1-10
Clinical Laboratory Safety Tests
Time frame: Part B:Dosing days 1 and 2: pre-dose (within 60 min before first dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18 and 24 (before second dosing) hours after drug administration+ day 3-10
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 21 Dec 2016.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
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 Volunteers, run by Galmed Pharmaceuticals Ltd 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 17 inclusion and 15 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 21 Dec 2016. 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 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?
Maximum plasma concentration (Cmax) (time frame: Part A:Pre-dose (within 60 min before dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 30, 36, 48(±60 min), 72 (±60 min), 96 (±60 min), 144 (±60 min) hours post-dose.Part C: Dosing days 1-10). 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 21 Dec 2016.