Healthy volunteers test new drug in early safety trial

NCT ID NCT03977974

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This Phase 1 study tested the safety and side effects of an experimental drug called LY3526318 in 76 healthy volunteers. The drug was given by mouth, and participants were monitored for up to 51 days. The trial was terminated early, so results may be limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY3526318
What could go wrong
This is a very early Phase 1 study in healthy people, so it cannot show any treatment benefit. The trial was terminated, meaning results may be incomplete.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

76 people

The number who actually took part.

Started

Jun 2019

Finished

Mar 2020

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 65 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: Part A Cohorts: \- Healthy male participants (including self-reported surgically sterile males) must agree to the following: * When engaging in sex with Women of Child-Bearing Potential (WOCBP) both the male participant and his female partner must use highly effective contraception consisting of 2 forms of birth control (1 of which must be a male barrier method such as a latex or polyurethane condom) from start of dosing throughout the clinical study period, and for 90 days after the final study drug administration * Nonsurgically sterile male participants must not donate sperm at any time from start of dosing until 90 days beyond the administration of study drug All Part A and Part B Cohorts: * Female participants must be nonpregnant and not lactating, or of nonchildbearing potential (either surgically sterilized \[e.g. tubal occlusion, hysterectomy, bilateral salpingectomy\] or physiologically incapable of becoming pregnant, or postmenopausal with amenorrhea for at least 12 consecutive months). Healthy female participants of child-bearing potential who have a fertile male sexual partner must be willing and able to practice effective contraception from admission to 30 days after the final visit. Sexually active participants must use a combination of 2 of the following methods of contraception, including at least 1 so-called 'barrier' method: * Hormonal contraceptive (oral, transdermal patches, vaginal or injectable) * Intrauterine device with or without hormones * Condom ('barrier' method) * Diaphragm or cervical cap * Sexual abstinence * Have a body mass index 18 to 32 kilograms per square meter (kg/m²) Exclusion Criteria: * Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study * Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality * In the opinion of the investigator are considered to be a danger to themselves * Have an abnormality in the 12-lead electrocardiogram (ECG) * Have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions * Have donated blood of more than 500 milliliter (mL) within the previous month * Are unwilling to stop alcohol and caffeinated beverage consumption and smoking/use of tobacco while resident in the CRU * Have an average weekly alcohol intake that exceeds 21 units per week (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits * Have an abnormal blood pressure * Participants with a history of drug abuse * Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) * Are unwilling to comply with the required dietary restrictions

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As listed by the trial registrant

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

Contacts and locations

Locations

  • PRA Health Sciences

    Groningen, 9728, Netherlands

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