A Phase 1 Study of the Safety and Pharmacokinetics of GC4711 (Oral Capsule) Compared to GC4419 (IV Infusion) and GC4711 (IV Infusion) in Healthy Volunteers

NCT ID: NCT03099824

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2020-01-27

Brief Summary

The purpose of the phase 1, GTO-003 clinical study is to determine the safety and pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral capsule. This study will compare capsules of GC4711 when given orally to a similar drug, GC4419, or GC4711 when either is given as an intravenous infusion.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GC4419 IV + GC4711 Oral G-101 (82mg)

Group Type: EXPERIMENTAL

GC4711 Oral Capsule G-101

Intervention Type: DRUG

82 mg (1 capsule)

IV GC4419

Intervention Type: DRUG

GC4419 will be infused IV as a single dose of 27 mg in 247 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump.

GC4419 IV + GC4711 Oral G-101 (164mg)

Group Type: EXPERIMENTAL

IV GC4419

Intervention Type: DRUG

GC4419 will be infused IV as a single dose of 27 mg in 247 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump.

GC4711 Oral Capsule G-101

Intervention Type: DRUG

164 mg (2 capsules)

GC4419 IV + GC4711 Oral G-101 (246mg)

Group Type: EXPERIMENTAL

IV GC4419

Intervention Type: DRUG

GC4419 will be infused IV as a single dose of 27 mg in 247 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump.

GC4711 Oral Capsule G-101

Intervention Type: DRUG

246 mg (3 capsules)

GC4419 IV + GC4711 Oral G-111 (175mg)

Group Type: EXPERIMENTAL

IV GC4419

Intervention Type: DRUG

GC4419 will be infused IV as a single dose of 27 mg in 247 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump.

GC4711 Oral Capsule G-111

Intervention Type: DRUG

175 mg (1 capsule)

GC4419 IV + GC4711 Oral G-112 (145mg)

Group Type: EXPERIMENTAL

IV GC4419

Intervention Type: DRUG

GC4419 will be infused IV as a single dose of 27 mg in 247 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump.

GC4711 Oral Capsule G-112

Intervention Type: DRUG

145 mg (1 capsule)

GC4711 IV + GC4711 Oral G-119 (233mg)

Group Type: EXPERIMENTAL

GC4711 Oral Capsule G-119

Intervention Type: DRUG

233 mg (1 capsule)

IV GC4711

Intervention Type: DRUG

GC4711 will be infused IV as a single dose of 30 mg in 250 mL normal saline, totaling 251 mL, over a 60-minute period using a programmable pump.

GC4711 IV + GC4711 Oral G-125 (233mg)

Group Type: EXPERIMENTAL

GC4711 Oral Capsule G-125

Intervention Type: DRUG

233 mg (1 capsule)

IV GC4711

Intervention Type: DRUG

GC4711 will be infused IV as a single dose of 30 mg in 250 mL normal saline, totaling 251 mL, over a 60-minute period using a programmable pump.

Interventions

GC4711 Oral Capsule G-101

82 mg (1 capsule)

Intervention Type: DRUG

IV GC4419

GC4419 will be infused IV as a single dose of 27 mg in 247 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump.

Intervention Type: DRUG

GC4711 Oral Capsule G-101

164 mg (2 capsules)

Intervention Type: DRUG

GC4711 Oral Capsule G-101

246 mg (3 capsules)

Intervention Type: DRUG

GC4711 Oral Capsule G-111

175 mg (1 capsule)

Intervention Type: DRUG

GC4711 Oral Capsule G-112

145 mg (1 capsule)

Intervention Type: DRUG

GC4711 Oral Capsule G-119

233 mg (1 capsule)

Intervention Type: DRUG

GC4711 Oral Capsule G-125

233 mg (1 capsule)

Intervention Type: DRUG

IV GC4711

GC4711 will be infused IV as a single dose of 30 mg in 250 mL normal saline, totaling 251 mL, over a 60-minute period using a programmable pump.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy men and women between 18 and 50 years (inclusive) of age;

2. Subjects who provide written informed consent

3. Body Mass Index (BMI) 18 to 32 kg/m2 (inclusive) and weighing at least 50 kg during Screening and at Baseline. Every effort will be made to enroll across BMI range to evaluate relation between dose and weight;

4. Subjects in general good health in the investigator's opinion

5. Chest X-ray free of clinically significant abnormalities

6. Blood pressure and heart rate within normal limits

7. Female subjects must:

1. Have a negative serum pregnancy test during Screening and a negative urine pregnancy test at Baseline, and be willing and able to use a medically acceptable method of birth control or be postmenopausal.

2. Be non-lactating

3. Be at least two years postmenopausal, surgically sterile or practicing effective contraception

Exclusion Criteria

1. History of clinically significant illness, medical condition, or laboratory abnormality within three months

2. History of any clinically significant cardiovascular, hepatic, renal, or gastrointestinal abnormality;

3. History of hypotension

4. Known contraindication, hypersensitivity and/or allergy to investigational products

5. Use of any prescription or over-the-counter medication within one week prior to baseline;

6. Anticipated need for any medication during the course of the study

7. Use of nitrates or erectile dysfunction drugs such as phosphodiesterase type 5 (PDE 5) inhibitors (e.g., sildenafil, tadalafil, or similar agents), from 24 hours prior to screening throughout participation in the study;

8. Use of or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure

9. Presence of orthostatic hypotension at screening or baseline

10. Use of any vitamin or mineral supplement 24 hours prior to dosing, or anticipated use of any vitamin or mineral supplement throughout the duration of the study;

11. Positive HIV, Hepatitis B or Hepatitis C serology at Screening;

12. Known history of substance abuse, drug addiction, or alcoholism within 3 years

13. Anticipated inability to abstain from alcohol, tobacco, or caffeine use from 48 hours prior to the administration of study drug and throughout the duration of the study;

14. Positive drug and alcohol toxicology screens during Screening and at Baseline;

15. History of smoking or any use of a tobacco product within six months prior to Baseline;

16. Donation of blood or blood products within 30 days prior to the Baseline and through duration of study;

17. Mentally unstable or incapable of being compliant with the protocol

18. Receipt of an investigational test substance within three months prior to the first dose of investigational products (GC4419, GC4711, or placebo), or anticipated receiving any investigational products (including placebo on another investigational study) other than GC4711 and GC4419 during the course of this study;

19. Subject has previously participated in this study, or in a prior study of GC4419, GC4711 or GC4702.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Galera Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon T Holmlund, MD

Role: STUDY_CHAIR

Chief Medical Officer

Locations

Nucleus Network

Melbourne, , Australia

Countries

Australia

Other Identifiers

GTO-003

Identifier Type: -

Identifier Source: org_study_id