Could a rectal antibiotic replace needles? early study underway
NCT ID NCT03895567
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 37 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 46 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The places running it
1 site. The list below names each one and where it is.
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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.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Faculty of Tropical Medicine, Mahidol University
Bangkok, Bangkok, 10400, Thailand
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