# Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC)

> **NCT03059303** · PHASE1 · TERMINATED · sponsor: **Janssen Research & Development, LLC** · enrollment: 72 (actual)

## Conditions studied

- Healthy

## Interventions

- **DRUG:** Simeprevir 75 mg
- **DRUG:** Odalasvir 25 mg
- **DRUG:** Odalasvir 12.5 mg
- **DRUG:** Odalasvir 75 mg
- **DRUG:** AL-335 800 mg
- **DRUG:** Lansoprazole 30 mg
- **DRUG:** Omeprazole 20 mg

## Key facts

- **NCT ID:** NCT03059303
- **Lead sponsor:** Janssen Research & Development, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2017-02-20
- **Primary completion:** 2017-04-24
- **Final completion:** 2017-04-24
- **Target enrollment:** 72 (ACTUAL)
- **Why stopped:** Decision to discontinue development of investigational Hep C treatment regimen JNJ-4178: 3 direct acting antivirals - AL-335, ODV \& SMV.
- **Last updated:** 2017-12-22


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03059303

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03059303, "Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC)". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT03059303. Licensed CC0.

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