HealthyEarly Phase 1NLG2111NCT03852446
Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers
A Early Phase 1 study testing Indoximod HCL (F2) tablets and Indoximod base formulation in people with Healthy, run by NewLink Genetics Corporation at 1 site in United States.
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 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. 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 HCL (F2) tablets and Indoximod base formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 14 Aug 2018
- Phase
- Early 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
- Non-smoker for at least 3 months
- BMI within 18 to 30 kg/m2
- Able to speak, read, and understand English or Spanish
Who cannot join
- Clinically significant cardiac, pulmonary, hepatic or renal disease
- History of substance abuse or alcohol dependence within past 2 years
- Inability to fast for a minimum of 14 hours
- Inability to swallow large capsules/tablets
- Pending legal charges or is on probation
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Services, Inc.
Secaucus, New Jersey, 07407
About this study
Official title: A Phase 1, Randomized Trial to Evaluate the Pharmacokinetics and Safety of Single Ascending Doses of Indoximod HCl (F2) Tablets (Part 1) and to Compare the Oral Bioavailability of Indoximod Cl (F2) Tablets and Indoximod Free Base Capsule Formulations and the Effect of Food (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 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. Part 2 is an open-label, randomized, 3-period, 3-way crossover study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state.
- Conditions
- Healthy
- Being tested
- Indoximod HCL (F2) tablets, Indoximod base formulation, Placebo
- Keywords
- Indoximod
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indoximod HCL (F2) tabletsDrug
The doses will be ascending per cohort from 600 mg to 2400 mg
Indoximod base formulationDrug
Single oral administration of 1200 mg
PlaceboOther
The matching placebo doses will be ascending per cohort from 1 to 4 tablets
Indoximod HCL (F2) tabletsDrug
Single oral administration of 1200 mg
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Ascending Dose | Experimental | Not described Receives: Drug: Indoximod HCL (F2) tablets; Other: Placebo |
| Part 2: Bioavailability and Food Effect | Experimental | 1. Single dose of Indoximod HCL (F2) formulation under fasting conditions
2. Single dose of Indoximod HCL (F2) formulation under fed conditions
3. Single dose of Indoximod base formulation under fasting conditions Receives: Drug: Indoximod base formulation; Drug: Indoximod HCL (F2) tablets |
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 2
Measured: up to 20 Days
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Part 2
Measured: up to 20 Days
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Part 1
Measured: up to 4 Days
Secondary outcomes (2)
Percentage of patients with adverse events
Part 1
Measured: up to 18 Days
Percentage of patients with adverse events
Part 2
Measured: up to 36 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start5 Mar 2018
- Primary completion5 Mar 2018
- Study completion14 Aug 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 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
- NCT03852446
- Sponsor's protocol ID
- NLG2111
- Acronym
- NLG2111
- Status last verified
- May 2020
- First submitted
- 21 Feb 2019
- 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 Evaluate the Pharmacokinetics and Safety of Single Ascending Doses of Indoximod HCl (F2) Tablets (Part 1) and to Compare the Oral Bioavailability of Indoximod Cl (F2) Tablets and Indoximod Free Base Capsule Formulations and the Effect of Food (Part 2) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03852446
- Acronym / sponsor ID
- NLG2111 / NLG2111
- Conditions
- Healthy
- Keywords
- Indoximod
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- NewLink Genetics CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 5 Mar 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 25 Feb 2019 (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 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. Part 2 is an open-label, randomized, 3-period, 3-way crossover study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state.
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: Single Ascending Dose | Experimental | Drug: Indoximod HCL (F2) tablets, Other: Placebo |
| Part 2: Bioavailability and Food Effect | Experimental | Drug: Indoximod base formulation, Drug: Indoximod HCL (F2) tablets1. Single dose of Indoximod HCL (F2) formulation under fasting conditions 2. Single dose of Indoximod HCL (F2) formulation under fed conditions 3. Single dose of Indoximod base formulation under fasting conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-smoker for at least 3 months
- BMI within 18 to 30 kg/m2
- Able to speak, read, and understand English or Spanish
Key exclusion criteria (5 listed)
- Clinically significant cardiac, pulmonary, hepatic or renal disease
- History of substance abuse or alcohol dependence within past 2 years
- Inability to fast for a minimum of 14 hours
- Inability to swallow large capsules/tablets
- Pending legal charges or is on probation
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 HCL (F2) tabletsThe doses will be ascending per cohort from 600 mg to 2400 mg | Drug | Part 1: Single Ascending Dose |
| Indoximod base formulationSingle oral administration of 1200 mg | Drug | Part 2: Bioavailability and Food Effect |
| PlaceboThe matching placebo doses will be ascending per cohort from 1 to 4 tablets | Other | Part 1: Single Ascending Dose |
| Indoximod HCL (F2) tabletsSingle oral administration of 1200 mg | Drug | Part 2: Bioavailability and Food Effect |
Primary outcome
Area Under the Plasma Concentration-Time Curve
Time frame: up to 20 Days
Part 2
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Time frame: up to 20 Days
Part 2
Pharmacokinetics: Serum concentrations (Cmax/Steady State)
Time frame: up to 4 Days
Part 1
2 secondary outcomes
Percentage of patients with adverse events
Time frame: up to 18 Days
Percentage of patients with adverse events
Time frame: up to 36 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 Early Phase 1 study testing Indoximod HCL (F2) tablets and Indoximod base formulation in people with Healthy, run by NewLink Genetics Corporation 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 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 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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; AzTrials last refreshed its copy on 31 Oct 2026.