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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

NCT ID: NCT03031574

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-23

Study Completion Date

2017-09-07

Brief Summary

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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

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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.

Conditions

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Cognitive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Food Effect

SUVN-D4010 tablets single dose

Group Type ACTIVE_COMPARATOR

SUVN-D4010

Intervention Type DRUG

Tablets

Gender Effect

SUVN-D4010 tablets single dose

Group Type ACTIVE_COMPARATOR

SUVN-D4010

Intervention Type DRUG

Tablets

Age Effect

SUVN-D4010 tablets single dose

Group Type ACTIVE_COMPARATOR

SUVN-D4010

Intervention Type DRUG

Tablets

Interventions

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SUVN-D4010

Tablets

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Suven Life Sciences Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Dickerson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

PRA Health Sciences

Locations

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PRA Health Sciences

Lenexa, Kansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33788154 (View on PubMed)

Other Identifiers

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CTP1S240105HT4

Identifier Type: -

Identifier Source: org_study_id