Phase 1
Completed N=44
Safety and Efficacy Study of DAV132 in Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT02176005 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcomePrimary: Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 16 Days After the Beginning of Treatment (AUC D1-D16) — 758.4; 8.28 μg/g.day — p=<.000001
Summary
The purpose of this study is to determine whether DAV132 is safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 16 Days After the Beginning of Treatment (AUC D1-D16) |
758.4; 8.28 | <.000001 sig |
| SECONDARY Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 37 Days After the Beginning of Treatment (AUC D1-D37) |
758.7; 8.74 | <.000001 sig |
| SECONDARY Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D1 |
42.1; 41.9 | 0.806 |
| SECONDARY Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D5 |
57.6; 50.5 | 0.139 |
| SECONDARY Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D1 |
4.02; 4.63 | 0.104 |
| SECONDARY Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D5 |
4.89; 4.60 | 0.519 |
| SECONDARY Number of Adverse Events (Including Abnormal Laboratory Findings) Related to Study Product |
1; 0; 0; 0 | — |
| SECONDARY Percentage of Subjects With Adverse Events Related to Study Product |
7.14; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers
- Normal digestive transit, with usually one daily stool.
- Females participating in the study :
must be either of non-child bearing potential (surgically sterilized at least 3 months prior to inclusion, or postmenopausal or having a negative pregnancy test and be not breastfeeding at screening, and using abstinence or a double contraception method during the treatment period and for additional period of 2 weeks after the end of investigational treatment.
- Having given and signed the written study informed consent prior to undertaking any study-related procedure.
- Covered by the French Health Insurance system.
Exclusion Criteria
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, bone and joint, muscular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness.
- Contra-indications to fluoroquinolones, or risk factors for adverse events associated to fluoroquinolones.
- Subjects with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency should be excluded.
- Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should be excluded.
- Contra-indications to DAV132, risk of gastrointestinal obstruction, perforation or haemorrhage, recent digestive tract surgery.
- Fecal colonisation by Clostridium difficile.
- Recent history of hospitalisation (within 3 months prior to inclusion).
- Any antibiotic administration within 3 months before inclusion.
- Any vaccination within the last 28 days.
Data sourced from ClinicalTrials.gov (NCT02176005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.