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HealthyPhase 1CefRECNCT03895567

Study to Compare Blood Levels of Ceftriaxone Given by Suppository or Injection.

A Phase 1 study testing A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection), B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg) and C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg) in people with Healthy, run by University of Oxford at 1 site in Thailand.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

Phase 1, three-way cross-over, randomised, open label comparison of intravenous versus two rectal dosage forms of ceftriaxone in 37 healthy Thai adults. The following regimens will be evaluated in random order in all participants: A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) B. Read more about this study

Who is it for?
Ages 18 to 46 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection), B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg) and C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteThailand
Study dates
Dec 2026to Dec 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 46 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Tropical Medicine, Mahidol University

    Bangkok, Bangkok, 10400

Other trials in Thailand

About this study

Official title: A Randomised Crossover Study of the Pharmacokinetics, Safety and Tolerability of Two Rectal Formulations of Ceftriaxone Compared to Parenteral Ceftriaxone, in Healthy Thai Adults.

Phase 1, three-way cross-over, randomised, open label comparison of intravenous versus two rectal dosage forms of ceftriaxone in 37 healthy Thai adults.

The following regimens will be evaluated in random order in all participants:

Read more
  1. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) B. Ceftriaxone rectal dosage form test formulation 1-hard-shell gelatin capsule (1 x 500mg) C. Ceftriaxone rectal dosage form test formulation 2-rectodispersible mannitol-based tablet (1 x 500mg)

Possible schedules: ABC, ACB, BAC, BCA, CAB, CBA. Each recipient will receive a single treatment dose of each of the three formulations in an order predetermined by a computer generated randomisation list. This will be a constrained randomization which ensures approximately balanced proportions for all six schedules (either 6 or 7 participants per schedule). There will be 7-28 days washout period between doses. The last follow up visit is 28 (+ 2) days after final dose. Participants lost to follow-up or unevaluable for any reason before completion of pharmacokinetic sampling after the final dose will be replaced at the discretion of the investigators with another participant of the same population, if either sample size or completeness of dataset is compromised.

This study is funded by the Medical Research Council. The grant reference number is MR/W021560/1

Conditions
Healthy
Being tested
A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection), B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg), C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg)

What participants receive

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

  • A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection)Drug

    Parenteral ceftriaxone

    Intravenous injection of 500mg of ceftriaxone sodium (Rocephin®; Roche).

  • B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg)Drug

    Rectal ceftriaxone formulations

    Formulation 1 ceftriaxone 500mg + Na-CDC 125mg hard-shell gelatin capsule

  • C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg)Drug

    Rectal ceftriaxone formulations

    Formulation 2 ceftriaxone 500mg + Na-CDC 125mg rectodispersible mannitol-based tablet

Study groups in NCT03895567
Study groupRoleWhat they receive
ABCExperimentalA. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) B. Ceftriaxone rectal dosage form test formulation 1- hard-shell gelatin capsule (1 x 500mg) C. Ceftriaxone rectal dosage form test formulation 2- rectodispersible mannitol-based tablet (1 x 500mg)
Receives: Drug: A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection); Drug: B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg); Drug: C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg)
ACBExperimentalA. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) C. Ceftriaxone rectal dosage form test formulation 2- rectodispersible mannitol-based tablet (1 x 500mg) B. Ceftriaxone rectal dosage form test formulation 1- hard-shell gelatin capsule (1 x 500mg)
Receives: Drug: A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection); Drug: B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg); Drug: C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg)
BACExperimentalB. Ceftriaxone rectal dosage form test formulation 1- hard-shell gelatin capsule (1 x 500mg) A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) C. Ceftriaxone rectal dosage form test formulation 2- rectodispersible mannitol-based tablet (1 x 500mg)
Receives: Drug: A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection); Drug: B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg); Drug: C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg)
BCAExperimentalB. Ceftriaxone rectal dosage form test formulation 1- hard-shell gelatin capsule (1 x 500mg) C. Ceftriaxone rectal dosage form test formulation 2- rectodispersible mannitol-based tablet (1 x 500mg) A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection)
Receives: Drug: A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection); Drug: B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg); Drug: C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg)
CABExperimentalC. Ceftriaxone rectal dosage form test formulation 2- rectodispersible mannitol-based tablet (1 x 500mg) A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) B. Ceftriaxone rectal dosage form test formulation 1- hard-shell gelatin capsule (1 x 500mg)
Receives: Drug: A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection); Drug: B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg); Drug: C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg)
CBAExperimentalC. Ceftriaxone rectal dosage form test formulation 2- rectodispersible mannitol-based tablet (1 x 500mg) B. Ceftriaxone rectal dosage form test formulation 1- hard-shell gelatin capsule (1 x 500mg) A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection)
Receives: Drug: A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection); Drug: B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg); Drug: C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg)

What is being measured

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

  1. Bioavailablity of rectal formulation

    Measured: Approximately 9 months

Secondary outcomes (6)

  1. Description of Exposure (AUC0-∞)

    Measured: Approximately 9 months

  2. Description of Peak concentration (Cmax)

    Measured: Approximately 100 days

  3. Description of Absorption rate (Tmax)

    Measured: Approximately 9 months

  4. Time above a plasma concentration of 1µg/mL (this concentration is above the MIC90 for major neonatal pathogens and is the lower limit of detection of the assay)

    Measured: Approximately 9 months

  5. Occurrence of serious adverse events (SAEs) from the date of the first dose to 28 days after the final dose, according to the MedDRA classification.

    Measured: Approximately 9 months

  6. Occurrence of all adverse events from the date of the first dose to 28 days after the final dose, according to the MedDRA classification.

    Measured: Approximately 9 months

Timeline

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

  1. First posted29 Mar 2019
  2. Study startDec 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Why it stopped: The study was suspended while the researchers secured new funding.

Resources

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
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03895567
Sponsor's protocol ID
BAC18003
Acronym
CefREC
Status last verified
Dec 2025
First submitted
27 Mar 2019
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: With participant's consent, participant's clinical data and results from blood analyses stored in our database may be shared with Biopharma Orofino Pharmaceuticals Group, regulatory authorities, or other researchers to use in the future. However, the other researchers will not be given any information that could identify the participant.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection), B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg) and C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg) in people with Healthy, run by University of Oxford at 1 site in Thailand.

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 3 inclusion and 23 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: paused, as of the sponsor's last update on 26 Dec 2025. 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 Thailand. 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?

Results are not available in the source record.

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?

Bioavailablity of rectal formulation (time frame: Approximately 9 months). 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 NCT03895567.

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 26 Dec 2025.

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