IDG-16177 for the Evaluation of Its Safety and Pharmacokinetics

NCT04982705 | Unknown Phase 1 DMC

• 2 other identifiers: IDG16177-T2DM-1012021-001082-21
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I, first-in-human, randomised, double-blinded, placebo-and active-controlled study to assess the safety, tolerability, PK, PD, efficacy, and food-effect of IDG-16177 in healthy male subjects and patients with T2DM at different dose levels.

Conditions

Type 2 Diabetes

Keywords

T2DM

Outcome Measures

Primary Outcomes (4)

• AEs/serious AEs (SAEs)

  Incidence and severity of adverse event

  Throughout study duration, up to 9 weeks

• Percentage of subjects with clinically significant change from baseline in vital signs

  Throughout study duration, up to 9 weeks

• Percentage of subjects with clinically significant change from baseline in electrocardiogram (ECG)

  Throughout study duration, up to 9 weeks

• Percentage of subejcts with clinically significant change from baseline in safety laboratory test results

  Throughout study duration, up to 9 weeks

Secondary Outcomes (10)

• Maximum concentration of IDG-16177(Cmax)

  Throughout study duration, up to 9 weeks

• Time of maximum plasma IDG-16177 concentration (Tmax)

  Throughout study duration, up to 9 weeks

• Area under the concentration-time curve (AUC)

  Throughout study duration, up to 9 weeks

• Terminal elimination rate constant (λz)

  Throughout study duration, up to 9 weeks

• Terminal elimination half-life calculated as: ln2/λz (T½)

  Throughout study duration, up to 9 weeks

Other Outcomes (6)

• Insulin

  Through the treatment; Plasma concentration will be observed at baseline and 0.25, 0.5, 1, 1.5, 2, 3 and 4 hours after dose

• proinsulin

  Through the treatment; Plasma concentration will be observed at baseline and 0.25, 0.5, 1, 1.5, 2, 3 and 4 hours after dose

• C-peptide

  Through the treatment; Plasma concentration will be observed at baseline and 0.25, 0.5, 1, 1.5, 2, 3 and 4 hours after dose

Study Arms (7)

[Part 1.1] IDG-16177

EXPERIMENTAL

6 subjects in each cohort (Cohort 1-5). The SAD study (Part 1.1) will consist of 5 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of IDG-16177 or placebo (6 active treatments and 2 placebo/3:1 ratio). Subjects in Cohort 4 will participate in a food-effect study.

Drug: [Part 1.1] IDG-16177

[Part 1.1] Placebo of IDG-16177

PLACEBO COMPARATOR

2 subjects in each cohort (Cohort 1-5). The SAD study (Part 1.1) will consist of 5 cohorts of 8 healthy subjects who will be randomised to receive a single oral dose of IDG-16177 or placebo (6 active treatments and 2 placebo/3:1 ratio). Subjects in Cohort 4 will participate in a food-effect study.

Drug: [Part 1.1] Placebo of IDG-16177

[Part 1.2] IDG-16177

EXPERIMENTAL

8 subjects in each cohort (Cohort 6-8). The MAD study (Part 1.2) will consist of 3 cohorts of 10 healthy subjects (8 active treatments and 2 placebo/4:1 ratio), each receiving an oral dose of IDG-16177 or placebo.

Drug: [Part1.2] IDG-16177

[Part 1.2] Placebo

PLACEBO COMPARATOR

2 subjects in each cohort (Cohort 6-8). The MAD study (Part 1.2) will consist of 3 cohorts of 10 healthy subjects (8 active treatments and 2 placebo/4:1 ratio), each receiving an oral dose of IDG-16177 or placebo (QD).

Drug: [Part 1.2] Placebo of IDG-16177

[Part 2] IDG-16177

EXPERIMENTAL

This part will consist of 3 separate arms of 8 patients per arm. Each arm will receive one of the following treatments: IDG-16177, placebo or DPP-4i as comparator.

Drug: [Part 2] IDG-16177

[Part 2] Placebo

PLACEBO COMPARATOR

This part will consist of 3 separate arms of 8 patients per arm. Each arm will receive one of the following treatments: IDG-16177, placebo or DPP-4i as comparator.

Drug: [Part 2] Placebo of IDG-16177

[Part 2] Sitagliptin

ACTIVE COMPARATOR

This part will consist of 3 separate arms of 8 patients per arm. Each arm will receive one of the following treatments: IDG-16177, placebo or DPP-4i as comparator (1:1:1 ratio).

Drug: [Part 2] Sitagliptin

Interventions

[Part 1.1] IDG-16177 DRUG

\[Part 1.1\] Subjects will receive a single oral dose of IMP. Dose strenght for each cohort (Cohort 1-5) is planned as 0.5, 1, 2, 5, 10mg, respectively.

[Part 1.1] IDG-16177

[Part 1.1] Placebo of IDG-16177 DRUG

\[Part 1.1\] subjects will receive a single oral dose of IMP.

[Part 1.1] Placebo of IDG-16177

[Part 2] Sitagliptin DRUG

Administration of Sitagliptin 100mg once daily for 4 weeks.

[Part 2] Sitagliptin

[Part1.2] IDG-16177 DRUG

\[Part 1.2\] Administration once daily for 14 days; Dose strenght for each cohort (Cohort 6-8) is planned as ≤ 2, ≤ 4, ≤ 8mg, respectively.

[Part 1.2] IDG-16177

[Part 2] IDG-16177 DRUG

\[Part 2\] Administration once daily for 4 weeks.

[Part 2] IDG-16177

[Part 1.2] Placebo of IDG-16177 DRUG

\[Part 1.2\] Administration once daily for 14 days.

[Part 1.2] Placebo

[Part 2] Placebo of IDG-16177 DRUG

\[Part 2\] Administration once daily for 4 weeks.

[Part 2] Placebo

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Part 1 and Part 2\] Subjects/Patients who meet the following criteria will be considered eligible to participate in Part 1 or Part 2 of the clinical study:
• \. Subject voluntarily/Patient agrees to participate in this study and signs an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures. 2. Subject/Patient is able to understand the nature of the clinical study. 3. Subject/Patient is able to read and speak German. 4. Subject/Patient is able to communicate satisfactorily with the Investigator and study team and follow the entire requirements of the clinical study. \[Part 1\] Subjects who meet the following criteria will be considered eligible to participate in Part 1 of the clinical study:
• Healthy male subjects aged 19 to 55 years at the time of Screening.
• Subject weighs at least 60 kg and has a body mass index (BMI)between 18.5 and 29.9 kg/m2, inclusive, at Screening.
• Subject who is healthy and judged to be eligible to participate in the study at the Screening test (based on medical history, physical examination, vital sign, 12 lead ECG, and laboratory test including serology test).
• \[Part 2\] Patients who meet the following criteria will be considered eligible to participate in Part 2 of the clinical study:
• Male patients aged 18 to 70 years at the time of Screening.
• Patient with T2DM who is taking metformin monotherapy as their only anti hyperglycemic treatment. Metformin dose must be stable, defined as no change in the treatment, including dose, for at least 2 months prior to the screening visit.
• Has a HbA1c level at Screening between 7.5% and 10.0%.
• Has a fasting plasma glucose level less than 13.3 mmol/L at Screening.
• Has a fasting C-peptide concentration greater than or equal to 0.8 ng/mL at Screening.
• If patient takes any chronic medications, the dose of these medications must have been stable (no change in dose or drug) for at least 4 weeks prior to Screening.
• Is able and willing to monitor glucose with a home glucose monitor and consistently record his blood glucose concentrations.
• Patient weighs at least 60 kg and has a BMI between 18.5 and 35 kg/m2, inclusive, at Screening.

You may not qualify if:

• \[Part 1 and Part 2\] Subjects/Patients who meet one or more of the following criteria will not be considered eligible to participate in Part 1 or Part 2 of the clinical study:
• Subject/Patient is an employee or a family member of the Sponsor or the involved CRO.
• Vulnerable subject (i.e., persons under any administrative or legal supervision or persons kept in detention).
• Subject/Patient who has a positive reverse transcription polymerase chain reaction (RT PCR) test for SARS-CoV-2 prior to randomisation.
• Subject/Patient who has clinical signs and symptoms consistent with SARS-CoV-2 infection; eg, fever, dry cough, dyspnea, sore throat, fatigue, or positive SARS-CoV-2 test result within 2 weeks prior to Screening.
• Subject/patient who had a severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated).
• Recent (within previous 14 days) exposure to someone who has COVID-19 symptoms or positive test result.
• Subject who has currently acute disease with active symptoms.
• History of clinically significant hypersensitivity reaction to any drugs or additives.
• Subjects who have a history of any gastrointestinal disease (Crohn's disease, ulcerative colitis, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy or herniotomy) which can affect the absorption of drugs.
• Subject who has participated in a clinical trial or bioequivalence test and have been administered in a product within 60 days or within 5 halflives of the drug, whichever is longer before the first study drug administration.
• Subject who have taken inducer or suppressor of metabolic enzymes such as barbiturates in 30 days before the first study drug administration.
• Subject who have donated whole blood in 60 days or who have donated plasma in 20 days before the first study drug administration.
• Subjects who have had any prescribed medicine or herbal medicine or who have had non-prescription medicine or vitamins within 7 days or 5 half lives before the first study drug administration, whichever is longer, except for occasional intake of paracetamol. Subjects who have received a SARS-CoV-2 vaccination within 4 weeks prior to screening or plan to be vaccinated during the study.
• Has a history of drug abuse or a history of alcohol abuse within 2 years prior to Screening.

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Parexel International GmbH Early Phase Clinical Unit Klinikum Westend

Berlin, 14050, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Central Study Contacts

ILDONG Pharmaceutical Co., Ltd.

CONTACT

+82(2)526-3441; jsy@ildong.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 29, 2021
• Study Start: July 7, 2021
• Primary Completion: November 9, 2022
• Study Completion: December 30, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

DE (1)