Food Effect in Healthy ParticipantsPhase 1NCT06988423

Evaluation of the Potential Impact of a High-fat Meal on the Pharmacokinetics of CRS3123 in Healthy Adult Participants

A Phase 1 study testing CRS3123 200 mg capsule in people with Food Effect in Healthy Participants, run by Crestone, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will explore the potential effects of high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 when administered as a single oral dose of 200 mg in healthy adult participants. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Food Effect in Healthy Participants
What is being tested?: CRS3123 200 mg capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 21 Apr 2025to 4 Jun 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Non-pregnant and non-lactating adults, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 64 years of age, with body mass index (BMI) > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males (as assigned at birth) and ≥ 45.0 kg for females (as assigned at birth), at the time of signing the informed consent.
Healthy as defined by:
the absence of clinically significant physical or laboratory findings (above Grade 1) and surgery within 4 weeks prior to dosing.
the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal (GI), renal, hepatic, and metabolic disease.
Healthy females (as assigned at birth) of non-childbearing potential must be:
postmenopausal (spontaneous amenorrhea for at least 12 months prior to dosing) with confirmation by documented follicle stimulating hormone (FSH) levels greater than or equal to 40 mIU/mL; or

Show all 9Show fewer

surgically sterile (bilateral oophorectomy, hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, bilateral salpingectomy, hysterectomy or tubal ligation) at least 3 months prior to dosing.
Sexually active females (as assigned at birth) of childbearing potential and non-sterile males (as assigned at birth) must be willing to use an acceptable contraceptive method throughout the study.
Able to understand the study procedures and provide signed informed consent to participate in the study.

Who cannot join

Any clinically significant abnormal finding at physical examination at screening that may interfere with the interpretation of safety and PK objectives of the study.
Abnormal laboratory test results (above Grade 1) that may interfere with the interpretation of safety and PK objectives of the study.
Positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antigen and antibody.
History of current or chronic liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Positive pregnancy test at screening or admission to the clinical research unit.
Positive urine drug screen, urine cotinine test, or alcohol test at screening or admission to the clinical research unit.

Show all 20Show fewer

Known allergic reactions to CRS3123 or other related drugs, or to any excipient in the formulation.
Use of medications within specified timeframes.
Previous exposure to CRS3123 within 12 months prior to the first dose.
Participants with HR < 50 or > 100 beats per minute (bpm), systolic blood pressure (SBP) < 90 or > 140 mmHg, diastolic blood pressure (DBP) < 50 or > 90 mmHg, on vital sign assessment at screening or admission to the clinical research unit.
A baseline ECG at screening with corrected QT interval (QTc) using Fridericia's formula (QTcF) > 450 msec.
Evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization). Any clinically significant (above Grade 1) conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular block [second degree or higher], Wolf Parkinson White syndrome), sinus pauses > 3 seconds, non sustained or sustained ventricular tachycardia (≥ 3 consecutive ventricular ectopic beats) or any significant arrhythmia which, in the opinion of the Investigator will interfere with the safety of the individual participant.
Participant has any surgical or medical condition (active or chronic) or GI tract condition (e.g., surgical resection of significant proportions of the stomach or bowel, gastric bypass, gastric banding, irritable bowel syndrome, inflammatory bowel disease, or any other condition that may interfere with normal gastric emptying or transit time) that may interfere with drug absorption, distribution, metabolism, or excretion of the study drug, or any other condition that may place the participant at risk, in the opinion of the Investigator.
Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days or 5× t½ (whichever is longer) prior to the first dose, administration of a biological product in the context of a clinical research study within 90 days or 5× t½ (whichever is longer) prior to the first dose or concomitant participation in an investigational study involving no drug or device administration.
Participants with serum creatinine level > 1.5 mg/dL.
History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units for women or 15 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to first dosing.
Participant is unable to comply with all the study procedures in the opinion of the Investigator.
Any reason the participant should not participate in the study in the opinion of the Investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

Syneos Health Miami
Miami, Florida, 33136

Other trials in United States

About this study

Official title: A Phase 1, Single-Center, Open-Label, Randomized, Single-Dose, 2-Period, Crossover Study to Evaluate the Potential Impact of High-fat Meal on the Pharmacokinetics of CRS3123 200 mg Capsule in Healthy Adult Participants

This study will explore the potential effects of high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 when administered as a single oral dose of 200 mg in healthy adult participants.

Read the detailed description

This study will assess the impact of a high-calorie and high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 in healthy adult participants when administered as a single oral capsule of 200 mg dose. Pharmacokinetics (PK) of a single dose of CRS3123 200 mg will be studied following administration to healthy participants under fed and fasted conditions.

Conditions: Food Effect in Healthy Participants
Being tested: CRS3123 200 mg capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CRS3123 200 mg capsuleDrug
CRS3123 200 mg capsule given as a single oral dose

Study groups in NCT06988423
Study group	Role	What they receive
Treatment A: 1 x 200 mg CRS3123 capsule administered under fasted conditions	Experimental	A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions. Receives: Drug: CRS3123 200 mg capsule
Treatment B: 1 x 200 mg CRS3123 capsule administered under fed conditions	Experimental	A single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions. Receives: Drug: CRS3123 200 mg capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of Food Effect Based on CRS3123 PK Parameters AUC0-t, AUC0-inf, and Cmax
CRS3123 PK parameters (AUC0-t, AUC0-inf, Cmax) values plotted against food status.
Note: no food-effect is assumed if the 90% CI for the ratio of geometric means (B (fed)/A (fasted), based on least-squares means from the ANOVA of the ln-transformed CRS3123 AUC0-inf (or AUC0-t) AND Cmax, is within 80.00% to 125.00% for CRS3123.
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of AUC0-t for CRS3123 Under Fasted vs Fed Conditions
Area under the concentration-time curve from time zero until the last observed concentration under fasted vs fed conditions
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of AUC0-inf for CRS3123 Under Fasted vs Fed Conditions.
Area under the concentration-time curve from time zero to infinity (extrapolated) under fasted vs fed conditions.
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Cmax for CRS3123 Under Fasted vs Fed Conditions
Maximal observed concentration under fasted vs fed conditions
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6

Secondary outcomes (10)

Calculation of Tmax for CRS3123 Under Fasted vs Fed Conditions
Time when the maximal concentration is observed under fasted vs fed conditions
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Tlag for CRS3123 Under Fasted vs Fed Conditions
Time of observation prior to the first observation with a measurable (non-zero) concentration under fasted vs fed conditions
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of t1/2 for CRS3123 Under Fasted vs Fed Conditions
Terminal elimination half-life under fasted vs fed conditions
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Kel for CRS3123 Under Fasted vs Fed Conditions
Terminal elimination rate constant under fasted vs fed conditions
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Cl/F for CRS3123 Under Fasted vs Fed Conditions
Apparent clearance under fasted vs fed conditions
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Vz/F for CRS3123 Under Fasted vs Fed Conditions
Apparent volume of distribution under fasted vs fed conditions
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Tmax for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
Time when the maximal concentration is observed under fasted vs fed conditions
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Tlag for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
Time of observation prior to the first observation with a measurable (non-zero) concentration under fasted vs fed conditions
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of t1/2 for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
Terminal elimination half-life under fasted vs fed conditions
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Kel for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
Terminal elimination rate constant under fasted vs fed conditions
Measured: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 20254 Jun 2025

First posted23 May 2025
Study start21 Apr 2025
Primary completion4 Jun 2025
Study completion4 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Food Effect in Healthy ParticipantsStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: In each period, participants will receive Treatment A or Treatment B according to the randomization scheme: * Treatment A: No food will be allowed from at least 10 hours before dosing until at least 4 hours after dosing. * Treatment B: After a supervised overnight fast of at least 10 hours, participants will be served a high-calorie and high-fat breakfast, in compliance with the FDA Guidance for Industry: Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations (2022). Breakfast will be served approximately 30 minutes prior to CRS3123 administration. Participants will fast for no less than 4 hours after study drug administration.
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06988423
Sponsor's protocol ID: 24-3123-FE
Other IDs: 75N93019C00056 (DMID 25-0002)
Status last verified: Mar 2026
First submitted: 16 May 2025
Last updated: 18 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single-Center, Open-Label, Randomized, Single-Dose, 2-Period, Crossover Study to Evaluate the Potential Impact of High-fat Meal on the Pharmacokinetics of CRS3123 200 mg Capsule in Healthy Adult Participants
ClinicalTrials.gov ID: NCT06988423
Acronym / sponsor ID: 24-3123-FE
Conditions: Food Effect in Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Crestone, IncIndustry (pharma, biotech, devices)
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 21 Apr 2025 (actual)
Primary completion: 4 Jun 2025 (actual)
Study completion: 4 Jun 2025 (actual)
First posted: 23 May 2025 (actual)
Results: Posted 18 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will explore the potential effects of high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 when administered as a single oral dose of 200 mg in healthy adult participants.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: In each period, participants will receive Treatment A or Treatment B according to the randomization scheme: * Treatment A: No food will be allowed from at least 10 hours before dosing until at least 4 hours after dosing. * Treatment B: After a supervised overnight fast of at least 10 hours, participants will be served a high-calorie and high-fat breakfast, in compliance with the FDA Guidance for Industry: Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations (2022). Breakfast will be served approximately 30 minutes prior to CRS3123 administration. Participants will fast for no less than 4 hours after study drug administration.

Arm	Type	Receives
Treatment A: 1 x 200 mg CRS3123 capsule administered under fasted conditions	Experimental	Drug: CRS3123 200 mg capsuleA single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fasted conditions.
Treatment B: 1 x 200 mg CRS3123 capsule administered under fed conditions	Experimental	Drug: CRS3123 200 mg capsuleA single 200 mg dose of CRS3123 administered orally as 1 × 200 mg capsule under fed conditions.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Non-pregnant and non-lactating adults, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 64 years of age, with body mass index (BMI) > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males (as assigned at birth) and ≥ 45.0 kg for females (as assigned at birth), at the time of signing the informed consent.
Healthy as defined by:
Healthy females (as assigned at birth) of non-childbearing potential must be:
Sexually active females (as assigned at birth) of childbearing potential and non-sterile males (as assigned at birth) must be willing to use an acceptable contraceptive method throughout the study.
Able to understand the study procedures and provide signed informed consent to participate in the study.

Key exclusion criteria (20 listed)

Any clinically significant abnormal finding at physical examination at screening that may interfere with the interpretation of safety and PK objectives of the study.
Abnormal laboratory test results (above Grade 1) that may interfere with the interpretation of safety and PK objectives of the study.
Positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus (HIV) antigen and antibody.
History of current or chronic liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Positive pregnancy test at screening or admission to the clinical research unit.

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
CRS3123 200 mg capsuleCRS3123 200 mg capsule given as a single oral dose	Drug	Treatment A: 1 x 200 mg CRS3123 capsule administered under fasted conditions, Treatment B: 1 x 200 mg CRS3123 capsule administered under fed conditions

Primary outcome

Assessment of Food Effect Based on CRS3123 PK Parameters AUC0-t, AUC0-inf, and Cmax
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
CRS3123 PK parameters (AUC0-t, AUC0-inf, Cmax) values plotted against food status. Note: no food-effect is assumed if the 90% CI for the ratio of geometric means (B (fed)/A (fasted), based on least-squares means from the ANOVA of the ln-transformed CRS3123 AUC0-inf (or AUC0-t) AND Cmax, is within 80.00% to 125.00% for CRS3123.
Calculation of AUC0-t for CRS3123 Under Fasted vs Fed Conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Area under the concentration-time curve from time zero until the last observed concentration under fasted vs fed conditions
Calculation of AUC0-inf for CRS3123 Under Fasted vs Fed Conditions.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Area under the concentration-time curve from time zero to infinity (extrapolated) under fasted vs fed conditions.
Calculation of Cmax for CRS3123 Under Fasted vs Fed Conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Maximal observed concentration under fasted vs fed conditions

10 secondary outcomes

Calculation of Tmax for CRS3123 Under Fasted vs Fed Conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Tlag for CRS3123 Under Fasted vs Fed Conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of t1/2 for CRS3123 Under Fasted vs Fed Conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Kel for CRS3123 Under Fasted vs Fed Conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Cl/F for CRS3123 Under Fasted vs Fed Conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Vz/F for CRS3123 Under Fasted vs Fed Conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Tmax for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Tlag for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of t1/2 for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Kel for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6

Results and safety

Results posted to the registry on 18 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1 (AB)	9	9
Sequence 2 (BA)	8	8

Primary outcome: Assessment of Food Effect Based on CRS3123 PK Parameters AUC0-t, AUC0-inf, and Cmax

Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6. Geometric least squares mean (90% Confidence Interval). Unit: Ratio

Measure	AUC0-t Ratio (Treatment B/Treatment A) n = 16	AUC0-inf Ratio (Treatment B/Treatment A) n = 16	Cmax Ratio (Treatment B/Treatment A) n = 16
Value	129.9 (107.4 to 157.0)	123.2 (97.7 to 155.5)	64.9 (51.6 to 81.6)

Population analysed: PK Statistical Population: All participants from the PK population and who did not experience any significant protocol deviations or other circumstances to exclude the participant from the PK statistical analysis.

Primary outcome: Calculation of AUC0-t for CRS3123 Under Fasted vs Fed Conditions

Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions n = 16	Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions n = 16
Value	1431.8 (57.9)	1885.5 (49.8)

Population analysed: PK Population: All participants from the Safety Population who completed the two periods, and for whom the PK profile could be adequately characterized (at least one primary PK parameter could be estimated for both periods for the comparison).

Primary outcome: Calculation of AUC0-inf for CRS3123 Under Fasted vs Fed Conditions.

Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions n = 14	Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions n = 15
Value	1616.8 (60.7)	1960.5 (44.6)

Primary outcome: Calculation of Cmax for CRS3123 Under Fasted vs Fed Conditions

Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions n = 16	Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions n = 16
Value	349.9 (43.6)	227.9 (44.6)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening (Day -28) through Day 11. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: 1 x 200 mg CRS3123 Capsule Administered Under Fasted Conditions	0 of 17 (0%)	5 of 17 (29.4%)	0 of 17
Treatment B: 1 x 200 mg CRS3123 Capsule Administered Under Fed Conditions	0 of 17 (0%)	6 of 17 (35.3%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 CRS3123 200 mg capsule in people with Food Effect in Healthy Participants, run by Crestone, Inc 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 9 inclusion and 20 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 18 Mar 2026. 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?

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?

Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Assessment of Food Effect Based on CRS3123 PK Parameters AUC0-t, AUC0-inf, and Cmax (time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6). 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?

On the ClinicalTrials.gov record for NCT06988423.

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 18 Mar 2026.