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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03031574
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Suven Life Sciences Limited

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.

Condition or disease Intervention/treatment Phase
Cognitive Disorder Drug: SUVN-D4010 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 23, 2017
Actual Primary Completion Date : August 29, 2017
Actual Study Completion Date : September 7, 2017

Arm Intervention/treatment
Active Comparator: Food Effect
SUVN-D4010 tablets single dose
Drug: SUVN-D4010
Tablets

Active Comparator: Gender Effect
SUVN-D4010 tablets single dose
Drug: SUVN-D4010
Tablets

Active Comparator: Age Effect
SUVN-D4010 tablets single dose
Drug: SUVN-D4010
Tablets




Primary Outcome Measures :
  1. Area under concentration (AUC) [ Time Frame: 72 hours ]
  2. Maximum observed concentration (Cmax) [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031574


Locations
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United States, Kansas
PRA Health Sciences
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Suven Life Sciences Limited
Investigators
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Principal Investigator: Daniel Dickerson, MD, PhD PRA Health Sciences
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Responsible Party: Suven Life Sciences Limited
ClinicalTrials.gov Identifier: NCT03031574    
Other Study ID Numbers: CTP1S240105HT4
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suven Life Sciences Limited:
Serotonin 4 (5-HT4) receptor
Phase 1
Additional relevant MeSH terms:
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Cognition Disorders
Neurocognitive Disorders
Mental Disorders