Single Oral Dose Escalation Study of DNDI-0690 in Healthy Subjects (NCT03929016) | Clinical Trial Compass
CompletedPhase 1
Single Oral Dose Escalation Study of DNDI-0690 in Healthy Subjects
United Kingdom64 participantsStarted 2019-04-04
Plain-language summary
This study will evaluate how the test medicine DNDI-0690 is taken up and broken down by the body and will also look at the safety and tolerability of the test medicine after a single dose. This is the first time the test medicine DNDI-0690 will be administered to humans.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Healthy males (Cohorts 1 to 7) or healthy WONCBP (Cohort 8)
* 18 to 55 years (Cohorts 1 to 7) or 18 to 60 years (Cohort 8)of age at the time of signing informed consent
* Body mass index (BMI) of 18.0 to 30.1 kg/m2 as measured at screening
* General good physical health determined by medical and surgical history, physical examination, 12-lead ECG, vital signs and clinical laboratory tests
* Normal blood pressure: Systolic blood pressure between ≥90 and ≤140 mmHg, Diastolic blood pressure ≤90 mmHg, measured after 10 min rest in supine position at screening, admission and pre-dose
* A resting Heart Rate (HR) between ≥40 and ≤90 bpm measured after 10 min rest in supine position at screening, admission and pre-dose
* ECG recording without clinically significant abnormality, including QTcF measure of ≤450 msec (male) or ≤470 msec (female) at screening, admission and pre-dose
* Having had no febrile seizures or infectious illness for at least 7 days prior to administration of the Investigational Medicinal Product (IMP)
* Must be willing and able to communicate and participate in the whole study
* Must provide written informed consent
* Must agree to adhere to the contraception requirements and life-style restrictions defined in the protocol
Exclusion Criteria:
* Subjects who have received any IMP in a clinical research study within the 3 months or 90 days prior to Day 1
* Subjects who are study site employees, or immediate family members of a study site or …
What they're measuring
1
Safety and Tolerability of DNDI-0690 by Assessing the Occurrence of Treatment-emergent adverse events (TEAEs)
Timeframe: from baseline up to 7-10 days post-dose
2
Safety and Tolerability of DNDI-0690 by Assessing the Changes in 12-lead electrocardiogram (ECG) parameters
Timeframe: from baseline up to 7-10 days post-dose
3
Safety and Tolerability of DNDI-0690 by Assessing the Changes of Safety laboratory parameters related to liver function
Timeframe: from baseline up 7-10 days post-dose
4
Safety and Tolerability of DNDI-0690 by Assessing the Changes of Safety laboratory parameters related to liver function
Timeframe: from baseline up 7-10 days post-dose
5
Safety and Tolerability of DNDI-0690 by Assessing the Changes of Safety laboratory parameters related to renal function
Timeframe: from baseline up 7-10 days post-dose
6
Safety and Tolerability of DNDI-0690 by Assessing the Changes of Safety laboratory parameters related to renal function
Timeframe: from baseline up 7-10 days post-dose
7
Safety and Tolerability of DNDI-0690 by Assessing the Changes of Troponin I as a cardiac safety marker