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Could a rectal antibiotic replace needles? early study underway

NCT ID NCT03895567

What the study statuses mean

This study's is highlighted.

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 early-stage study tests whether a common antibiotic (ceftriaxone) can be given as a rectal suppository instead of an injection. 37 healthy Thai adults will try both forms to compare how well the drug is absorbed and any side effects. The goal is to find a needle-free option that could be easier to use, especially for babies or in low-resource settings.

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

About 37 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 46 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: * Healthy male or non-pregnant female, aged 18 to 46 years (inclusive) * Willing and able to give informed consent to participate in the trial * Able, in the investigators opinion, and willing to comply with the study requirements and followup. Exclusion Criteria: * Female participant who is pregnant, lactating or planning pregnancy during the course of the study. * Presence of any condition which in the judgment of the investigator would affect the absorption of the rectal formulation e.g. previous surgery, haemorrhoids, inflammatory bowel disease * Irritable bowel syndrome (IBS) or diarrhoea in the 24 hours prior to study drug administration * Presence of any condition which in the judgment of the investigator would place the participant at undue risk or interfere with the results of the study (e.g. serious underlying cardiac, renal, hepatic or neurological disease; severe malnutrition; congenital defects or febrile condition). * Seropositive for HIV at screening * Hepatitis B surface antigen (HBsAg) detected in serum at screening. * Seropositive for hepatitis C virus (antibodies to HCV) at screening * Participation in a clinical trial and/or has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication and throughout the study period. * Any medical condition that in the judgment of the investigator would make the administration of the study treatments unsafe. * Use of medications known to have a potentially clinically significant interaction with ceftriaxone or with sodium chenodeoxycholate (Na-CDC) in the 28 days prior to the first dose and throughout the study period. This includes aluminium-containing antacids, colestipol, phenobarbital and the combined oral contraceptive pill. * Known 27-hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis) * History of anaphylaxis and /or hypotension, laryngeal oedema, wheezing, angioedema or urticarial rash following treatment with ceftriaxone, another cephalosporin or any beta lactam (e.g. penicillin). * History of any other clinically significant reaction to ceftriaxone, another cephalosporin or beta lactam e.g. drug induced nephritis, hepatitis, erythema multiforme that, in the opinion of the investigator, contraindicates participation in the study. * Serious chronic illness. * Abnormal baseline laboratory screening test as defined below: * AST \> 2 x upper normal limit * ALT \> 2 x upper normal limit * Anaemia (Hb \< 11 g/dL for female and Hb \< 12 g/dL for male), * Platelets \< 150,000 * Total bilirubin \> 2 x upper normal limit * Hepatomegaly, right upper quadrant abdominal pain or tenderness. * Body Mass Index\> 35 * History of alcohol or substance abuse or dependence during the 6 months before study participation: History of regular alcohol consumption averaging \>7 drinks/week for women or \>14 drinks/week for men. One drink is equivalent to 12 g alcohol = 5 oz (150 mL) of wine or 12 oz (360 mL) of beer or 1.5 oz (45 mL) of 80 proof distilled spirits.

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As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Faculty of Tropical Medicine, Mahidol University

    Bangkok, Bangkok, 10400, Thailand

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