A Phase 1 Clinical Study to Investigate the Pharmacokinetics and Safety/Tolerability of SA001 in Healthy Male Volunteers

NCT02470286 | Completed Phase 1

• 1 other identifier: SJSA001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this phase1 study is to investigate the pharmacokinetics, safety and tolerability of a single oral dose of SA001 and its active metabolite in healthy male volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The incidence of treated related adverse event

  Safety/Tolerability Assessment in the part 1

  Part1: Day-2(administration) to approximately Day 15 (Post study visit)

Secondary Outcomes (9)

• Area under the curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of SA001 and its metabolite

  Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose

• Area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-∞) of SA001 and its metabolite

  Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose

• Maximum observed plasma concentration (Cmax) of SA001 and its metabolite

  Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose

• Time to reach the maximum observed plasma concentration (tmax) of SA001 and its metabolite

  Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose

• t1/2 of SA001 and its metabolite

  Part1: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose, Part2: predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 32, and 48 hours postdose

Study Arms (5)

Cohort 1 (SA001 60mg or Placebo)

EXPERIMENTAL

6 subjects receiving a single dose of 60mg SA001 and 2 subjects receiving placebo

Drug: SA001 60mg or Placebo

Cohort 2 (SA001 120mg or Placebo)

EXPERIMENTAL

6 subjects receiving a single dose of 120mg SA001 and 2 subjects receiving placebo

Drug: SA001 120mg or Placebo

Cohort 3 (SA001 180mg or Placebo)

EXPERIMENTAL

6 subjects receiving a single dose of 180mg SA001 and 2 subjects receiving placebo

Drug: SA001 180mg or Placebo

Cohort 4 (SA001 240mg or Placebo)

EXPERIMENTAL

6 subjects receiving a single dose of 240mg SA001 and 2 subjects receiving placebo

Drug: SA001 240mg or Placebo

Cohort 5 (SA001 300mg or Placebo)

EXPERIMENTAL

6 subjects receiving a single dose of 300mg SA001 and 2 subjects receiving placebo

Drug: SA001 300mg or Placebo

Interventions

SA001 60mg or Placebo DRUG

* Study Drug: SA001 60mg * Comparator: Placebo * Cohort 1 in the part 1 (Dose escalation study)

Cohort 1 (SA001 60mg or Placebo)

SA001 120mg or Placebo DRUG

* Study Drug: SA001 120mg * Comparator: Placebo * Cohort 2 in the part 1 (Dose escalation study) and part 2 (Food effect study)

Cohort 2 (SA001 120mg or Placebo)

SA001 180mg or Placebo DRUG

* Study Drug: SA001 180mg * Comparator: Placebo * Cohort 3 in the part 1 (Dose escalation study)

Cohort 3 (SA001 180mg or Placebo)

SA001 240mg or Placebo DRUG

* Study Drug: SA001 240mg * Comparator: Placebo * Cohort 4 in the part 1 (Dose escalation study)

Cohort 4 (SA001 240mg or Placebo)

SA001 300mg or Placebo DRUG

* Study Drug: SA001 300mg * Comparator: Placebo * Cohort 5 in the part 1(Dose escalation study) and part 2 (Food effect study)

Cohort 5 (SA001 300mg or Placebo)

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years to 45 years (Healthy male Korean)
• Body weight of 55 to 90kg; and BMI of 18.0 to 27.0 kg/m\^2
• Subject who voluntarily agrees to participate in this study and has given a written informed consent, after fully understanding the detailed explanation of this study

You may not qualify if:

• Subject with a disease history of any clinically significant condition as below.
• \- Liver, Kidney, nervous system, immune system, respiratory system, endocrine system, tumor, cardiovascular disease or mental illness (mood disorder or obsessive-compulsive disorder etc.) etc.
• Subject with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendicectomy or hernia surgery) that may affect the absorption of the study drug
• Subject with a history of clinically significant hypersensitivity or hypersensitivity reactions to drugs (aspirin, antibiotics, etc.)
• Serum ALT(SGPT)/AST(SGOT) \>1.5×institutional upper limit normal (ULN)
• eGFR\< 90mL/min/1.73m\^2
• Systolic blood pressure \<100 mmHg or \>160 mmHg
• Diastolic blood pressure \<60 mmHg or \>100 mmHg
• Inadequate cardiac function confirmed by 12-lead ECG findings at screening as followings:
• QTcF \> 430msec (males)
• PR interval \> 200msec or \< 110msec
• QRS complex \> 120msec
• Evidence of 2nd- or 3rd-degree atrioventricular (AV) block
• Pathologic Q waves (defined as Q-wave \> 40msec or depth \> 0.5mV)
• Evidence of ventricular preexicitation, left bundle branch block (LBBB), right bundle branch block (RBBB, Incomplete RBBB)

Sponsors & Collaborators

• Samjin Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Kyung-sang Yu, M.D., Ph.D., M.B.A

  Seoul National University College of Medicine / Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 12, 2015
• Study Start: June 29, 2015
• Primary Completion: September 18, 2015
• Study Completion: September 30, 2015
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

KR (1)