Healthy volunteers help test new pain pill absorption

NCT ID NCT07341152

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two different tablet forms of an experimental pain drug (LTG-001) in 14 healthy adults to see how well each is absorbed. Participants took single doses of each version, and researchers measured drug levels in the blood. The goal was to find which formulation works best for future pain management treatments.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

14 people

The number who actually took part.

Started

Oct 2025

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures. * Must be willing and able to comply with all study requirements Aged 18 to 55 years inclusive at the time of signing informed consent. * Must agree to use an adequate method of contraception (as defined in Section 9.4. * Healthy males or non-pregnant, non-lactating, healthy females. * Body mass index of 18.0 to 32.0 kg/m2 as measured at screening. * Weight ≥50 kg at screening. Exclusion Criteria: * Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients. * Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active. * Significant serious skin disease, including rash, food allergy, eczema, psoriasis, or urticaria. * History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease (except cholecystectomy), neurological or psychiatric disorder, as judged by the investigator. * Have poor venous access that limits phlebotomy. * Clinically significant abnormal clinical chemistry, hematology or urinalysis as judged by the investigator (laboratory parameters are listed in Appendix 1). Participants with Gilbert's Syndrome are allowed. * Has ALT or AST \>1.5 × ULN; Total bilirubin \>1.5 × ULN (for participants with known Gilbert's syndrome these criteria only apply if the total bilirubin \>1.5 × ULN as long as direct bilirubin is ≤1.5 × ULN) at screening. * Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of \<90 mL/min using the Cockcroft-Gault equation * Positive HBsAg, HCV Ab or HIV antibody results at screening. * Positive serum pregnancy test at screening or positive urine pregnancy test at first * Participants who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IMP and first dose be less than 30 days. * Participants who report to have previously received LTG-001. admission. Those who are pregnant or lactating will be excluded. * Personal or family history of long QT syndrome or a QTcF interval \> 450 msec for men or \> 470 for women on screening or first admission ECG. Participants who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g per day acetaminophen, HRT or oral contraception) in the 14 days before IMP administration (see Section 11.4). Exceptions may apply on a case-by-case basis, if considered not to interfere with the objectives of the study, as determined by the investigator. * Participants who have had any vaccine within 15 days before first IMP administration History of any drug or alcohol abuse in the past 2 years. * Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine). * A confirmed positive alcohol urine test at screening or first admission. * Current smokers and those who have smoked within the last 12 months. * Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months. * A confirmed positive urine cotinine test at screening or first admission. * Positive drug screen test result at screening or first admission (drug of abuse tests are listed in Appendix 1) Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication. * Participants who are, or are immediate family members of, a study site or sponsor employee. * Failure to satisfy the investigator of fitness to participate for any other reason.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Quotient Sciences - Miami, Inc

    Miami, Florida, 33126, United States

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