NCT02518568

Brief Summary

The purpose of this study is to investigate the pharmacokinetics of serum iron after a single oral administration of 160 mg (2 tablets of 80 mg) V0355 in women with iron deficiency anaemia.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2015

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

9 months

First QC Date

August 4, 2015

Last Update Submit

September 27, 2016

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (3)

  • Maximum Plasma concentration (Cmax)

    up to 24 hours after oral administration

  • Time to Maximum Concentration (Tmax)

    up to 24 hours after oral administration

  • Area under the iron plasma concentration curve (AUC)

    up to 24 hours after oral administration

Secondary Outcomes (1)

  • Tolerability of single administration

    Up to 24 hours

Study Arms (1)

Drug

EXPERIMENTAL
Drug: V0355

Interventions

V0355DRUG

Oral administration (2 tablets)

Drug

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women 18-45 years inclusive with iron deficiency anaemia
  • haemoglobin level between 85 g/L and 105 g/L
  • serum ferritin level \< 15 µg/L
  • D14 +/- 7 days of the menstruation cycle on the day of pharmacokinetic evaluation

You may not qualify if:

  • Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure,
  • Haemochromatosis or iron overload of secondary origin (blood transfusion),
  • Long term treatment known to modify iron absorption,
  • Gastro duodenal ulcer,
  • Inflammatory bowel disease or any digestive disease which could modify iron absorption,
  • Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders),
  • Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Sofia, Bulgaria

Location

Unknown Facility

Iași, Romania

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 10, 2015

Study Start

August 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 28, 2016

Record last verified: 2016-09

Locations

BU(1)RO(1)