A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-D4010 in Healthy Subjects

• ClinicalTrials.gov Identifier: NCT03031574
• Recruitment Status: Completed
• First Posted: January 25, 2017
• Last Update Posted: September 25, 2017
• Sponsor: Suven Life Sciences Limited
• Information provided by (Responsible Party): Suven Life Sciences Limited

Tracking Information

• First Submitted Date: January 23, 2017
• First Posted Date: January 25, 2017
• Last Update Posted Date: September 25, 2017
• Actual Study Start Date: January 23, 2017
• Actual Primary Completion Date: August 29, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 23, 2017)

• Area under concentration (AUC) [ Time Frame: 72 hours ]
• Maximum observed concentration (Cmax) [ Time Frame: Day 1 ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-D4010 in Healthy Subjects
• Official Title: A Phase 1, Single-Center, Single-Dose, 2-Way Crossover, Randomized Food-Effect and Non-Randomized Gender- and Age- Effect Pharmacokinetic Study of SUVN-D4010 Orally Administered in Healthy Subjects
• Brief Summary: The purpose of the study is to evaluate the effect of food, gender, and age on the single-dose pharmacokinetics (PK) of SUVN-D4010.
• Detailed Description: The main objective of the study is to evaluate the safety and tolerability of orally administered SUVN-D4010 under single-dose conditions in healthy adult male and female subjects and healthy elderly male subjects.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cognitive Disorder

Intervention

Drug: SUVN-D4010

Tablets

Study Arms

• Active Comparator: Food Effect
  SUVN-D4010 tablets single dose
  Intervention: Drug: SUVN-D4010
• Active Comparator: Gender Effect
  SUVN-D4010 tablets single dose
  Intervention: Drug: SUVN-D4010
• Active Comparator: Age Effect
  SUVN-D4010 tablets single dose
  Intervention: Drug: SUVN-D4010

• Publications *: Nirogi R, Bhyrapuneni G, Muddana NR, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. First-in-Human Studies to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel 5-HT4 Partial Agonist, SUVN-D4010, in Healthy Adult and Elderly Subjects. Clin Drug Investig. 2021 May;41(5):469-482. doi: 10.1007/s40261-021-01027-4. Epub 2021 Mar 31.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 23, 2017): 28
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 7, 2017
• Actual Primary Completion Date: August 29, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy male subjects, aged 18 to 45 years, inclusive; healthy female subjects, aged 18 to 45 years, inclusive; healthy elderly male subjects, aged ≥65 years.
• Have a body mass index (BMI) between 18.0 and 30.0kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg.

Exclusion Criteria:

• History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the (first) administration of the study drug.
• Any positive result at Screening for serum hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus antibody.
• Plasma or blood product donation within 1 month of the (first) administration of the study drug and any blood donation/blood loss more than 500 mL within the 2 months prior to the (first) administration of the study drug.
• As judged by the Investigator that the subject should not participate in the study if he/she is considered unlikely to comply with study procedures, restrictions, and requirements.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03031574
• Other Study ID Numbers: CTP1S240105HT4
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Suven Life Sciences Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Suven Life Sciences Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Daniel Dickerson, MD, PhD; PRA Health Sciences

• PRS Account: Suven Life Sciences Limited
• Verification Date: September 2017