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

NCT03099824 | Completed Phase 1 FDA Drug

• 1 other identifier: GTO-003
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events and Laboratory Abnormalities

  Number of Participants With Treatment-Emergent Adverse Events and/or Laboratory Abnormalities.

  From randomization through study completion (estimated up to 13 days)

Study Arms (7)

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

EXPERIMENTAL

Drug: GC4711 Oral Capsule G-101; Drug: IV GC4419

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

EXPERIMENTAL

Drug: IV GC4419; Drug: GC4711 Oral Capsule G-101

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

EXPERIMENTAL

Drug: IV GC4419; Drug: GC4711 Oral Capsule G-101

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

EXPERIMENTAL

Drug: IV GC4419; Drug: GC4711 Oral Capsule G-111

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

EXPERIMENTAL

Drug: IV GC4419; Drug: GC4711 Oral Capsule G-112

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

EXPERIMENTAL

Drug: GC4711 Oral Capsule G-119; Drug: IV GC4711

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

EXPERIMENTAL

Drug: GC4711 Oral Capsule G-125; Drug: IV GC4711

Interventions

GC4711 Oral Capsule G-101 DRUG

82 mg (1 capsule)

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

IV GC4419 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); GC4419 IV + GC4711 Oral G-101 (246mg); GC4419 IV + GC4711 Oral G-101 (82mg); GC4419 IV + GC4711 Oral G-111 (175mg); GC4419 IV + GC4711 Oral G-112 (145mg)

GC4711 Oral Capsule G-111 DRUG

175 mg (1 capsule)

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

GC4711 Oral Capsule G-112 DRUG

145 mg (1 capsule)

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

GC4711 Oral Capsule G-119 DRUG

233 mg (1 capsule)

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

GC4711 Oral Capsule G-125 DRUG

233 mg (1 capsule)

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

IV GC4711 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-119 (233mg); GC4711 IV + GC4711 Oral G-125 (233mg)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women between 18 and 50 years (inclusive) of age;
• Subjects who provide written informed consent
• 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;
• Subjects in general good health in the investigator's opinion
• Chest X-ray free of clinically significant abnormalities
• Blood pressure and heart rate within normal limits
• Female subjects must:
• 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.
• Be non-lactating
• Be at least two years postmenopausal, surgically sterile or practicing effective contraception

You may not qualify if:

• History of clinically significant illness, medical condition, or laboratory abnormality within three months
• History of any clinically significant cardiovascular, hepatic, renal, or gastrointestinal abnormality;
• History of hypotension
• Known contraindication, hypersensitivity and/or allergy to investigational products
• Use of any prescription or over-the-counter medication within one week prior to baseline;
• Anticipated need for any medication during the course of the study
• 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;
• Use of or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
• Presence of orthostatic hypotension at screening or baseline
• 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;
• Positive HIV, Hepatitis B or Hepatitis C serology at Screening;
• Known history of substance abuse, drug addiction, or alcoholism within 3 years
• 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;
• Positive drug and alcohol toxicology screens during Screening and at Baseline;
• History of smoking or any use of a tobacco product within six months prior to Baseline;

Sponsors & Collaborators

• Galera Therapeutics, Inc.: lead

Study Sites (1)

Nucleus Network

Melbourne, Australia

Location

MeSH Terms

Interventions

avasopasem manganese

Study Officials

• Jon T Holmlund, MD

  Chief Medical Officer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 4, 2017
• Study Start: October 16, 2018
• Primary Completion: January 27, 2020
• Study Completion: January 27, 2020
• Last Updated: March 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)