A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis

Summary

This trial will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of multiple oral doses of OPC-167832 in participants with uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis (TB).

Conditions

• Pulmonary TB

Interventions

DRUG

10 mg OPC-167832

Once daily oral dose of 10 mg OPC-167832 from Day 1 through Day 14.

DRUG

30 mg OPC-167832

Once daily oral dose of 30 mg OPC-167832 from Day 1 through Day 14.

DRUG

90 mg OPC-167832

Once daily oral dose of 90 mg OPC-167832 from Day 1 through Day 14.

DRUG

3 mg OPC-167832

Once daily oral dose of 3 mg OPC-167832 from Day 1 through Day 14.

DRUG

RHEZ

RHEZ was used in both Stage 1 and Stage 2. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 400 mg pyrazinamide, and 275 mg ethambutol. Participants received a single-dose from Day 1 through Day 20. The total number of tablets per day was based on the pretreatment body weight: * Participants weighing 30 to 37 kg received 2 tablets per day * Participants weighing 38 to 54 kg received 3 tablets per day * Participants weighing 55 to 70 kg received 4 tablets per day * Participants weighing \> 70 kg received 5 tablets per day

DRUG

30 mg OPC-167832 + 300 mg delamanid

Once daily oral dose of 30 mg OPC-167832 plus 300 mg delamanid from Day 1 through Day 14.

DRUG

30 mg OPC-167832 + 400 mg BDQ

Once daily oral dose of 30 mg OPC-167832 plus 400 mg BDQ from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. The dose of BDQ was 400 mg QD for Days 3 to 14.

DRUG

30 mg OPC-167832 + 300 mg delamanid + 400 mg BDQ

Once daily oral dose of 30 mg OPC-167832 plus 300 mg delamanid plus 400 mg BDQ from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. The dose of BDQ was 400 mg QD for Days 3 to 14.

Sponsors & Collaborators

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Otsuka Pharmaceutical Development & Commercialization, Inc.

  lead INDUSTRY

Principal Investigators

• Veronique R de Jager, MD · TASK Clinical Research Centre

• Prof. Rodney Dawson, MD · University of Cape Town (Pty) Ltd.

• Prof. Andreas Diacon · TASK Clinical Research Centre (TCRC)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-18

Primary Completion

2022-02-14

Completion

2022-03-11

FDA Drug

Yes

Countries

• South Africa

Study Locations