Nonalcoholic SteatohepatitisPhase 1NCT04887038
First-in-Human Study of SRT-015 in Healthy Subjects.
A Phase 1 study testing SRT-015 in people with Nonalcoholic Steatohepatitis, run by Syneos Health at 1 site in Australia.
Trial summary
This is phase 1 first-in-human trial evaluating SRT-015 to assess safety, tolerability and pharmacokinetics. This study will be conducted in 3 parts - SAD, MAD and Food Effect with target of 96 healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- SRT-015
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteAustralia
- Study dates
- 3 May 2021to 28 Feb 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females aged 18 to 45 years of age with a BMI >18.0 and <32.0 kg/m2 and body weight greater than or equal to 50kg for males and greater than or equal to 45 kg for females.
- Casual smoker (defined by the consumption of no more than 5 cigarettes per week, and willing to abstain from the consumption of cigarettes and related products for the study duration) or non smoker.
- Agree to use appropriate contraception.
Who cannot join
- Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results (liver function tests must be strictly within normal ranges) or positive test for HIV, hepatitis B, or hepatitis C found during medical screening.
- Positive urine drug screen or alcohol breath test at screening and check-in (Day -1).
- Positive pregnancy test, or breast feeding.
- Clinically significant 12-lead ECG abnormalities.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single and Multiple Dose-escalation First-in-human With Food-effect Study Evaluating the Safety, Tolerability and Pharmacokinetics of SRT-015 Administered Orally.
This is phase 1 first-in-human trial evaluating SRT-015 to assess safety, tolerability and pharmacokinetics. This study will be conducted in 3 parts - SAD, MAD and Food Effect with target of 96 healthy volunteers.
This will be a single center, Phase 1, randomized, double-blind, placebo controlled, SAD and MAD study of dose escalation cohorts evaluating administration of SRT-015 or placebo. Additionally, PK will be assessed in fed and fasting states.
Read the detailed description
The study will be divided into three parts:
Part A: SAD- Randomized, double-blind, placebo-controlled single oral escalating dose of SRT-015 or placebo in five cohorts (A1-A5). Each cohort will include 8 healthy subjects (6 randomized to receive SRT-015 and 2 to receive placebo). Two subjects from each cohort (1 to receive SRT-015 and 1 to receive placebo) will be dosed as sentinels, with the remainder of the subjects of each cohort (5 to receive SRT-015 and 1 to receive placebo) dosed at least the following day.
An extension cohort (Cohort A6) will allow investigation of a repeat or intermediate dose, at the discretion of the Sponsor or Safety Review Committee (SRC).
Part B: MAD- Randomized, double-blind, placebo-controlled multiple oral escalating dose of SRT-015 or placebo in four cohorts (B1-B4). Each cohort will include 8 healthy subjects (6 randomized to receive SRT-015 and 2 to receive placebo). Subjects will be treated with SRT-015 or placebo for 7 days.
An extension cohort (Cohort B5) will allow investigation of a repeat or intermediate dose at the discretion of Sponsor and SRC.
Part C: Food Effect (FE)- Randomized, crossover oral SRT-015 dose study of 8 healthy adults divided into two concurrent groups where half (n=4) of the subjects (Cohort C1) will receive the first dose as an oral suspension in fasting state on Day 1 of Period 1, the second dose as capsule formulation in fasting state on Day 1 of Period 2 and the third dose as a capsule formulation in a fed state on Day 1 of Period 3. The remainder (n=4) of the subjects (Cohort C2) will receive the first dose as an oral suspension in fasting state on Day 1 of Period 1, the second dose as a capsule formulation in a fed state on Day 1 of Period 2 and the third dose as a capsule formulation in a fasting state on Day 1 of Period 3.
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- SRT-015, Matching Placebo for SRT-015
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRT-015Drug
Each study part (A,B and C) will be completed sequentially, but with partial overlapping. The first cohort of Part B (Cohort B1) may be initiated after safety, tolerability and available PK data are assessed and deemed suitable to continue for a single dose on Part A that is equal to or greater than the total exposure of cohort B1. Part C (Cohort C1 \& C2) may be initiated after safety, tolerability and PK data are assessed and deemed suitable to continue for a single dose in part A that is at least double the specified dose from part C.
Matching Placebo for SRT-015Other
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Drug :SRT-015 | Active comparator | Experimental, Single and Multiple Oral escalating dose and Food Effect Cohort Receives: Drug: SRT-015 |
| Matching Placebo for SRT-015 | Placebo comparator | Not described Receives: Other: Matching Placebo for SRT-015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability following of single and multiple oral doses of SRT-015 in healthy subjects
Number of participants with serious and other non-serious adverse events
Measured: Up to two weeks
To evaluate the exposure to SRT-015 following single and multiple oral dose administration in healthy subjects (AUC last)
Area under the serum concentration-time curve from time zero to last measurable concentration (mg*h/L)
Measured: Up to two weeks
3. To evaluate maximum serum concentration of SRT-015 following single and multiple oral dose administration in healthy subjects (Cmax)
Maximum serum concentration (mg/L)
Measured: Up to two weeks
Secondary outcomes (2)
To compare the exposure to SRT-015 (AUClast) in capsule formulation vs suspension formulation and fed vs fasted state
Comparison of the area under the serum concentration-time curve from time zero to last measurable concentration after administration of SRT-015 after a meal v in a fasting state (mg*h/L)
Measured: Up to two weeks
To compare maximum serum concentration of SRT-015 (Cmax) in capsule formulation vs suspension formulation and fed v fasted state
Maximum serum concentration (mg/L)
Measured: Up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start3 May 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic SteatohepatitisStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneos Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887038
- Sponsor's protocol ID
- SRT015-01
- Status last verified
- Apr 2022
- First submitted
- 5 May 2021
- Last updated
- 20 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single and Multiple Dose-escalation First-in-human With Food-effect Study Evaluating the Safety, Tolerability and Pharmacokinetics of SRT-015 Administered Orally.
- ClinicalTrials.gov ID
- NCT04887038
- Acronym / sponsor ID
- SRT015-01
- Conditions
- Nonalcoholic Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Syneos HealthUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 14 May 2021 (actual)
- 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 phase 1 first-in-human trial evaluating SRT-015 to assess safety, tolerability and pharmacokinetics. This study will be conducted in 3 parts - SAD, MAD and Food Effect with target of 96 healthy volunteers.
This will be a single center, Phase 1, randomized, double-blind, placebo controlled, SAD and MAD study of dose escalation cohorts evaluating administration of SRT-015 or placebo. Additionally, PK will be assessed in fed and fasting states.
Detailed description
The study will be divided into three parts:
Part A: SAD- Randomized, double-blind, placebo-controlled single oral escalating dose of SRT-015 or placebo in five cohorts (A1-A5). Each cohort will include 8 healthy subjects (6 randomized to receive SRT-015 and 2 to receive placebo). Two subjects from each cohort (1 to receive SRT-015 and 1 to receive placebo) will be dosed as sentinels, with the remainder of the subjects of each cohort (5 to receive SRT-015 and 1 to receive placebo) dosed at least the following day.
An extension cohort (Cohort A6) will allow investigation of a repeat or intermediate dose, at the discretion of the Sponsor or Safety Review Committee (SRC).
Part B: MAD- Randomized, double-blind, placebo-controlled multiple oral escalating dose of SRT-015 or placebo in four cohorts (B1-B4). Each cohort will include 8 healthy subjects (6 randomized to receive SRT-015 and 2 to receive placebo). Subjects will be treated with SRT-015 or placebo for 7 days.
An extension cohort (Cohort B5) will allow investigation of a repeat or intermediate dose at the discretion of Sponsor and SRC.
Part C: Food Effect (FE)- Randomized, crossover oral SRT-015 dose study of 8 healthy adults divided into two concurrent groups where half (n=4) of the subjects (Cohort C1) will receive the first dose as an oral suspension in fasting state on Day 1 of Period 1, the second dose as capsule formulation in fasting state on Day 1 of Period 2 and the third dose as a capsule formulation in a fed state on Day 1 of Period 3. The remainder (n=4) of the subjects (Cohort C2) will receive the first dose as an oral suspension in fasting state on Day 1 of Period 1, the second dose as a capsule formulation in a fed state on Day 1 of Period 2 and the third dose as a capsule formulation in a fasting state on Day 1 of Period 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug :SRT-015 | Active comparator | Drug: SRT-015Experimental, Single and Multiple Oral escalating dose and Food Effect Cohort |
| Matching Placebo for SRT-015 | Placebo comparator | Other: Matching Placebo for SRT-015 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males or females aged 18 to 45 years of age with a BMI >18.0 and <32.0 kg/m2 and body weight greater than or equal to 50kg for males and greater than or equal to 45 kg for females.
- Casual smoker (defined by the consumption of no more than 5 cigarettes per week, and willing to abstain from the consumption of cigarettes and related products for the study duration) or non smoker.
- Agree to use appropriate contraception.
Key exclusion criteria (5 listed)
- Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results (liver function tests must be strictly within normal ranges) or positive test for HIV, hepatitis B, or hepatitis C found during medical screening.
- Positive urine drug screen or alcohol breath test at screening and check-in (Day -1).
- Positive pregnancy test, or breast feeding.
- Clinically significant 12-lead ECG abnormalities.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
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 |
|---|---|---|
| SRT-015Each study part (A,B and C) will be completed sequentially, but with partial overlapping. The first cohort of Part B (Cohort B1) may be initiated after safety, tolerability and available PK data are assessed and deemed suitable to continue for a single dose on Part A that is equal to or greater than the total exposure of cohort B1. Part C (Cohort C1 \& C2) may be initiated after safety, tolerability and PK data are assessed and deemed suitable to continue for a single dose in part A that is at least double the specified dose from part C. | Drug | Drug :SRT-015 |
| Matching Placebo for SRT-015Matching Placebo | Other | Matching Placebo for SRT-015 |
Primary outcome
To evaluate the safety and tolerability following of single and multiple oral doses of SRT-015 in healthy subjects
Time frame: Up to two weeks
Number of participants with serious and other non-serious adverse events
To evaluate the exposure to SRT-015 following single and multiple oral dose administration in healthy subjects (AUC last)
Time frame: Up to two weeks
Area under the serum concentration-time curve from time zero to last measurable concentration (mg*h/L)
3. To evaluate maximum serum concentration of SRT-015 following single and multiple oral dose administration in healthy subjects (Cmax)
Time frame: Up to two weeks
Maximum serum concentration (mg/L)
2 secondary outcomes
To compare the exposure to SRT-015 (AUClast) in capsule formulation vs suspension formulation and fed vs fasted state
Time frame: Up to two weeks
To compare maximum serum concentration of SRT-015 (Cmax) in capsule formulation vs suspension formulation and fed v fasted state
Time frame: Up to two weeks
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 20 Apr 2022.
- Individual participant dataSharing planned: No
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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.
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 SRT-015 in people with Nonalcoholic Steatohepatitis, run by Syneos Health at 1 site in Australia.
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 5 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 20 Apr 2022. 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 Australia. 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 evaluate the safety and tolerability following of single and multiple oral doses of SRT-015 in healthy subjects (time frame: Up to two weeks). The study lists 3 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 20 Apr 2022.