Measuring concentrations of the drug atazanavir along the gastrointestinal tract in human subjects after oral administration of the drug product

Gastrointestinal behavior of atazanavir in healthy volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004579-29-BE

Enrollment

Registered

2018-01-23

Start date

2018-02-08

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy human volunteers

Interventions

Trade Name: Reyataz, 300 mg harde capsules Pharmaceutical Form: Capsule, hard INN or Proposed INN: ATAZANAVIR SULFATE CAS Number: 229975-97-7 Other descriptive name: ATAZANAVIR SULFATE Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Healthy volunteers - Age between 18 and 40 years old Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Disease - Acute/chronic GI condition - Use of medication - Pregnancy - frequent exposure to X-rays during the past year - HIV / HBV / HCV infection

Design outcomes

Primary

Measure	Time frame
Main Objective: The study aims to investigatie principles of supersaturation and precipitation of a weakly basic drug atazanavir along the gastrointestinal tract in healthy human volunteers. The influence of acidic and calory-containing beverages will also be investigated.;Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Measure

Time frame

Main Objective: The study aims to investigatie principles of supersaturation and precipitation of a weakly basic drug atazanavir along the gastrointestinal tract in healthy human volunteers. The influence of acidic and calory-containing beverages will also be investigated.;Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactPatrick Augustijns

KU Leuven

patrick.augustijns@kuleuven.be003216330301

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026