HealthyPhase 1NCT03372239
Oral Bioavailability,and Food Effect Study and Single Ascending Dose PK Study in Healthy Male Volunteers
A Phase 1 study testing Indoximod base formulation and Indoximod HCL (salt) formulation in people with Healthy, run by NewLink Genetics Corporation at 1 site in Canada.
Trial summary
This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Indoximod base formulation and Indoximod HCL (salt) formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 21 Nov 2017to 16 Apr 2018
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects 18 to 55 years of age, inclusive.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2, and a minimum weight of 50.0 kg.
- Non-smoker for at least 3 months prior to Screening.
- Male subjects with female sexual partners of childbearing potential must be using and willing to continue using medically acceptable contraception
- Signed and dated written informed consent
Who cannot join
- History or presence of any clinically significant abnormality, illness, or disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the validity of the results of the study.
- Subjects with autoimmune conditions, inflammatory bowel disease, rheumatoid arthritis, and/or subjects who have undergone an organ transplant.
- Self-reported history of substance or alcohol dependence within the past 2 years, and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
- Any medical/surgical procedure or trauma within 4 weeks of the first study drug administration or planned within 1 month of study completion.
- Positive urine drug screen.
- Positive breath alcohol test.
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- Evidence of clinically significant hepatic or renal impairment
- Inability to fast for a minimum of 14 hours.
- Inability to swallow large capsules/tablets.
- Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).
- Donation or loss of more than 500 mL whole blood within 1 month preceding entry into the Treatment phase and throughout the study.
- Difficulty with venous access or unsuitable or unwilling to undergo catheter insertion.
- History of severe allergic reaction (including anaphylaxis) to any substance, or previous status asthmaticus.
- Treatment with an investigational drug within 5 times the elimination half-life, if known (eg, a marketed product), or within 30 days (if the elimination half-life is unknown) prior to first drug administration or is concurrently enrolled in any research judged not to be scientifically or medically compatible with this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized Trial to Compare the Oral Bioavailability of Indoximod Salt and Base Formulations and the Effect of Food (Part 1) and to Evaluate the PK and Safety of Single Ascending Doses of Indoximod (Part 2) in Healthy Male Volunteers
This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state. Part 2 is a randomized single ascending dose study of indoximod salt formulation to characterize the PK profile and determine the safety and tolerability of each dose in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- Indoximod base formulation, Indoximod HCL (salt) formulation, Placebo
- Keywords
- Indoximod
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indoximod base formulationDrug
Specified dose on specified days
Indoximod HCL (salt) formulationDrug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Bioavailability and Food Effect | Experimental | Subjects will be randomized to receive the following 3 regimens in randomized sequence:
1. Single dose of Indoximod base formulation under fasting conditions
2. Single dose of Indoximod HCL (salt) formulation under fed conditions
3. Single dose of Indoximod HCL (salt) formulation under fasting conditions Receives: Drug: Indoximod base formulation; Drug: Indoximod HCL (salt) formulation; Other: Placebo |
| Part 2: Single Ascending Dose | Experimental | Not described Receives: Drug: Indoximod HCL (salt) formulation; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve
Part 1 (Food Effect)
Measured: up to 20 Days
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Part 1 (Food Effect)
Measured: up to 20 Days
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Part 2 (Single rising dose)
Measured: up to 4 Days
Secondary outcomes (2)
Percentage of patients with adverse events
Part 1
Measured: up to 34 Days
Percentage of patients with adverse events
Single rising dose
Measured: up to 16 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start21 Nov 2017
- Primary completion25 Jan 2018
- Study completion16 Apr 2018
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewLink Genetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugene Kennedy, MD, Study director, NewLink Genetics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372239
- Sponsor's protocol ID
- NLG2108
- Status last verified
- May 2020
- First submitted
- 10 Dec 2017
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized Trial to Compare the Oral Bioavailability of Indoximod Salt and Base Formulations and the Effect of Food (Part 1) and to Evaluate the PK and Safety of Single Ascending Doses of Indoximod (Part 2) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03372239
- Acronym / sponsor ID
- NLG2108
- Conditions
- Healthy
- Keywords
- Indoximod
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- NewLink Genetics CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 16 Apr 2018 (actual)
- First posted
- 13 Dec 2017 (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 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is an open-label, 3-period, 6-sequence study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state. Part 2 is a randomized single ascending dose study of indoximod salt formulation to characterize the PK profile and determine the safety and tolerability of each dose in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Bioavailability and Food Effect | Experimental | Drug: Indoximod base formulation, Drug: Indoximod HCL (salt) formulation, Other: PlaceboSubjects will be randomized to receive the following 3 regimens in randomized sequence: 1. Single dose of Indoximod base formulation under fasting conditions 2. Single dose of Indoximod HCL (salt) formulation under fed conditions 3. Single dose of Indoximod HCL (salt) formulation under fasting conditions |
| Part 2: Single Ascending Dose | Experimental | Drug: Indoximod HCL (salt) formulation, Other: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects 18 to 55 years of age, inclusive.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2, and a minimum weight of 50.0 kg.
- Non-smoker for at least 3 months prior to Screening.
- Male subjects with female sexual partners of childbearing potential must be using and willing to continue using medically acceptable contraception
- Signed and dated written informed consent
Key exclusion criteria (14 listed)
- History or presence of any clinically significant abnormality, illness, or disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the validity of the results of the study.
- Subjects with autoimmune conditions, inflammatory bowel disease, rheumatoid arthritis, and/or subjects who have undergone an organ transplant.
- Self-reported history of substance or alcohol dependence within the past 2 years, and/or has ever participated or plans to participate in a substance or alcohol rehabilitation program to treat their substance or alcohol dependence.
- Any medical/surgical procedure or trauma within 4 weeks of the first study drug administration or planned within 1 month of study completion.
- Positive urine drug screen.
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 |
|---|---|---|
| Indoximod base formulationSpecified dose on specified days | Drug | Part 1: Bioavailability and Food Effect |
| Indoximod HCL (salt) formulationSpecified dose on specified days | Drug | Part 1: Bioavailability and Food Effect, Part 2: Single Ascending Dose |
| PlaceboSpecified dose on specified days | Other | Part 1: Bioavailability and Food Effect, Part 2: Single Ascending Dose |
Primary outcome
Area Under the Plasma Concentration-Time Curve
Time frame: up to 20 Days
Part 1 (Food Effect)
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Time frame: up to 20 Days
Part 1 (Food Effect)
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Time frame: up to 4 Days
Part 2 (Single rising dose)
2 secondary outcomes
Percentage of patients with adverse events
Time frame: up to 34 Days
Percentage of patients with adverse events
Time frame: up to 16 Days
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 28 May 2020.
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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.
Eugene Kennedy, MD study director
NewLink Genetics Inc
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 Indoximod base formulation and Indoximod HCL (salt) formulation in people with Healthy, run by NewLink Genetics Corporation at 1 site in Canada.
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 14 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 28 May 2020. 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 Canada. 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?
Area Under the Plasma Concentration-Time Curve (time frame: up to 20 Days). 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 28 May 2020.