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

NCT ID: NCT03895567

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-12-31

Study Completion Date

2026-12-31

Brief Summary

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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. 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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ABC

A. 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)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Parenteral ceftriaxone

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

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

Intervention Type 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)

Intervention Type DRUG

Rectal ceftriaxone formulations

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

ACB

A. 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)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Parenteral ceftriaxone

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

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

Intervention Type 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)

Intervention Type DRUG

Rectal ceftriaxone formulations

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

BAC

B. 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)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Parenteral ceftriaxone

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

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

Intervention Type 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)

Intervention Type DRUG

Rectal ceftriaxone formulations

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

BCA

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Parenteral ceftriaxone

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

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

Intervention Type 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)

Intervention Type DRUG

Rectal ceftriaxone formulations

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

CAB

C. 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)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Parenteral ceftriaxone

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

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

Intervention Type 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)

Intervention Type DRUG

Rectal ceftriaxone formulations

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

CBA

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Parenteral ceftriaxone

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

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

Intervention Type 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)

Intervention Type DRUG

Rectal ceftriaxone formulations

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

Interventions

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

Parenteral ceftriaxone

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

Intervention Type DRUG

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

Rectal ceftriaxone formulations

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

Intervention Type DRUG

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

Rectal ceftriaxone formulations

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

46 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biopharma (Orofino Pharmaceuticals Group)

UNKNOWN

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Ashley, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol Oxford Tropical Medicine Research Unit

Locations

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Faculty of Tropical Medicine, Mahidol University

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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BAC18003

Identifier Type: -

Identifier Source: org_study_id